NovationRecalls & reported problems across all models
Exactech, Inc. · 184 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
24 open recalls name at least one Novation model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,145
- Deaths reported
- 0
- Injuries reported
- 1,124
- Recalls
- 25
We found 184 models of Novation by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 1,145 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2019 and Sep 25, 2026 — classified as 1,124 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (928 reports).
25 FDA recall records name at least one of these models by its device identifier, 24 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Novation recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 31, 2024Open, Classified
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Z-1166-2025 · Root cause: Nonconforming Material/Component · names 70 of these models · Recall details · FDA record ↗
- Nov 21, 2023Open, Classified
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Z-0581-2024 · Root cause: Packaging change control · Recall details · FDA record ↗
- Aug 11, 2022Open, Classified
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Z-1732-2022 · Root cause: Process control · names 16 of these models · Recall details · FDA record ↗
- Aug 11, 2022Open, Classified
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Z-1731-2022 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
- Aug 11, 2022Open, Classified
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Z-1730-2022 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
- Aug 11, 2022Open, Classified
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Z-1729-2022 · Root cause: Process control · names 35 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2133-2021 · Root cause: Unknown/Undetermined by firm · names 5 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2132-2021 · Root cause: Unknown/Undetermined by firm · names 12 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2131-2021 · Root cause: Unknown/Undetermined by firm · names 2 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2130-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2129-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2128-2021 · Root cause: Unknown/Undetermined by firm · names 4 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2127-2021 · Root cause: Unknown/Undetermined by firm · names 5 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2126-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2125-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2123-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2122-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2121-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2120-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2119-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2118-2021 · Root cause: Unknown/Undetermined by firm · names 4 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2117-2021 · Root cause: Unknown/Undetermined by firm · names 5 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2116-2021 · Root cause: Unknown/Undetermined by firm · names 3 of these models · Recall details · FDA record ↗
- Jun 29, 2021Open, Classified
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Z-2115-2021 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- Nov 7, 2016Terminated
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Z-1030-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Novation problems
Device problems
- Naturally Worn928
- Adverse Event Without Identified Device or Use Problem180
- Insufficient Device Problem Information152
- Loosening of Implant Not Related to Bone-Ingrowth95
- Unstable31
- Fracture24
- Device Dislodged or Dislocated22
- Mechanical Problem15
Patient problems
- Failure of Implant578
- Osteolysis471
- Pain366
- Insufficient Information306
- Implant Pain126
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available116
- Synovitis101
- Discomfort85
Novation models
184 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Novation 130-32-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
- Novation 130-32-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls97 reports
- Novation 130-36-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- Novation 130-36-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls46 reports
- Novation 136-32-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 136-36-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls38 reports
- Novation 130-32-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls33 reports
- Novation 132-36-53Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls28 reports
- Novation 130-28-51Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls27 reports
- Novation 136-32-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls26 reports
- Novation 132-32-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 reports
- Novation 130-28-50Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls19 reports
- Novation 132-40-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls19 reports
- Novation 132-28-51Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls15 reports
- Novation 136-32-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls14 reports
- Novation 138-32-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls14 reports
- Novation 130-40-53Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls12 reports
- Novation 138-36-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls9 reports
- Novation 132-40-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls9 reports
- Novation 132-36-54Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls5 reports
- Novation 130-40-54Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls5 reports
- Novation 136-40-54Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls5 reports
- Novation 136-36-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls4 reports
- Novation 136-40-53Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls4 reports
- Novation 130-28-52Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls3 reports
- Novation 132-32-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls3 reports
- Novation 130-32-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls2 reports
- Novation 130-36-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Novation 132-28-50Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Novation 132-32-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Novation 136-32-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls2 reports
- Novation 138-36-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls2 reports
- Novation 132-40-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Novation 132-28-52Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls1 report
- Novation 132-32-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls1 report
- Novation 132-36-55Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls1 report
- Novation 136-36-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls1 report
- Novation 138-32-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls1 report
- Novation 138-36-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls1 report
- Novation 130-22-70Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 130-32-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 132-22-70Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 134-36-45Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- Novation 136-28-51Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Novation 136-32-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 138-32-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 138-36-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 130-40-55Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Novation 138-40-53Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Novation 138-40-54Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Novation 138-40-55Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Novation 136-40-55Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Novation 132-36-52Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall41 reports
- Novation 140-36-52Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall8 reports
- Novation 142-36-62Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall6 reports
- Novation 140-36-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall4 reports
- Novation 140-32-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall2 reports
- Novation 140-32-52Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall2 reports
- Novation 146-36-52Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- Novation 148-36-52Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- Novation 160-70-15Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall1 report
- Novation 140-36-54Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 140-40-54Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall1 report
- Novation 142-32-61Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall1 report
- Novation 142-36-64Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall1 report
- Novation 142-40-63Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall1 report
- Novation 134-28-41Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Novation 134-32-42Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Novation 134-36-43Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Novation 134-36-44Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Novation 136-22-70Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 136-28-50Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 136-28-52Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 138-22-70Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 138-28-50Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 138-28-51Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Novation 138-32-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Novation 138-32-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 140-22-70Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 140-28-50Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 140-28-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 140-28-52Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 140-32-53Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 140-32-54Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 140-32-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 140-36-55Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 140-40-53Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 140-40-55Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-22-70Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 142-28-50Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-28-51Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Novation 142-28-52Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-32-51Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-32-52Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- Novation 142-32-53Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
- Novation 142-32-54Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- Novation 142-32-55Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented1 recall0 reports
Recent Novation adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Loss of Osseointegration
It was reported that the patient underwent an initial left total hip arthroplasty. Subsequently, it was reported that the patient experienced pain, osteolysis, prosthesis wear and acetabular loosening. As a result, the patient underwent a left hip revision approximately 7 years after initial implantation. Patient was last known to be in stable condition. No further information available.
Patient problems: Aseptic loosening; Osteolysis; Pain
MAUDE report 50897461 ↗InjurySep 25, 2026Naturally Worn
As reported, approximately 10 years and 7 months post the initial right total hip arthroplasty, the patient was experiencing pain and stiffness and was shown to have early wear on imaging. The patient underwent a revision where the acetabular poly liner and femoral head were swapped. There was no reported breakage of a device or surgical delay/prolongation. The patient was last known to be in stable condition following the event.
Patient problems: Pain; Unspecified Musculoskeletal problem
MAUDE report 50896798 ↗InjurySep 18, 2026Naturally Worn
It was reported that the patient underwent a hip replacement. Subsequently, the patient experienced persistent hip pain, inflammation, and limited mobility. Additional symptoms included noises, clicking sensations, and a feeling of instability while walking. Radiographic evaluation reportedly confirmed loosening and osteolysis. Due to these findings, the treating orthopedic surgeon recommended revision surgery to remove and replace the affected implant components. The outcome of the revision procedure, if performed, was not reported. No further information is available.
Patient problems: Inflammation; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain
MAUDE report 50820557 ↗InjurySep 14, 2026Naturally Worn
Patient problems: Inflammation; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain
MAUDE report 50757250 ↗InjurySep 8, 2026Naturally Worn
Approximately 8 years after implantation of a left total hip prosthesis, the patient developed groin discomfort that progressed to pain. Radiographic imaging and bone scan findings did not indicate loosening of the prosthetic components. However, a large granulomatous lesion was identified in the region of implant wear and was associated with suspected polyethylene wear.The patient underwent revision surgery. During the procedure, the granuloma was excised, and the bearing surface components were replaced. The metal implant components were reported to be well-fixed and well-integrated with the surrounding bone. Areas of osteolysis were reconstructed using allograft bone graft material. No further information is available.
Patient problems: Granuloma; Osteolysis; Pain
MAUDE report 50670175 ↗InjurySep 8, 2026Loss of Osseointegration
Report #2 of 2 for this event.As reported, due to the manufacturer's recall campaign, the patient that is five (5) years post-op the initial total hip arthroplasty, came in to have the hip prosthesis checked. Radiograph control revealed a clear decentering of the prosthetic head and unusually coarse osteolysis in the acetabulum as signs of premature inlay deterioration. The socket component was completely loosened. The patient was revised to another manufacturer's construct. No additional information is available.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50669729 ↗InjurySep 2, 2026Loss of Osseointegration
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Pain
MAUDE report 50572095 ↗InjuryAug 31, 2026Loosening of Implant Not Related to Bone-Ingrowth
Report #2 of 2 for this event.As reported via legal documentation this patient had a right total hip arthroplasty. Subsequently, five (5) years, four (4) months later the patient underwent a revision procedure due to prosthesis wear. A revision operative report was provided. Intraoperatively, the femoral stem was determined to be loose. The patient tolerated the procedure well. No further information is available.
Patient problems: Insufficient Information
MAUDE report 50532344 ↗InjuryAug 26, 2026Naturally Worn
Patient problems: Pain
MAUDE report 50456479 ↗InjuryJul 10, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE LINER BECAME DEFECTIVE. AS A RESULT, THE PATIENT UNDERWENT A HIP REVISION AN UNKNOWN AMOUNT OF TIME AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25779166 ↗InjuryJun 29, 2026Unstable; Naturally Worn; Lack of Effect
IT WAS REPORTED A PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, NINE (9) YEARS LATER, THE PATIENT PRESENTED WITH PAIN, ACHINESS AND LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE WITH A COMPLEX RECONSTRUCTION OF THE LEFT ACETABULUM. A REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, THE PATIENT WAS NOTED TO HAVE EXTENSIVE OSTEOLYSIS. THE FEMORAL STEM APPEARED STABLE. THE ACETABULAR CUP WAS MOBILE. THEY NOTED THE SIGNIFICANT DEFORMITY OF THE ACETABULUM WITH FRAGMENTING OF THE ACETABULAR LINER. DUE TO THE PATIENT'S SUPRAACETABULAR DEFECT, IT WAS NOTED TO BE DIFFICULT TO GET A GOOD PURCHASE ON THE NEW IMPLANT WITH THE ELECTED SCREW, HOWEVER, UPON REPOSITIONING THE CUP AND USING A BIGGER SCREW, THE PURCHASE WAS SUCCESSFUL AND NOTED TO HAVE A VERY STABLE FIXATION WITH THE BIGGER SCREW. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ADDITIONALLY, IT WAS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT ENDURED JOINT PAIN SWELLING AND STIFFNESS, TISSUE DAMAGE, INSTABILITY, PROSTHESIS WEAR, AND BONE GRAFT.
Patient problems: Aseptic loosening; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Scar Tissue; Swelling/ Edema
MAUDE report 25660688 ↗InjuryJun 16, 2026Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT THA, UNDERWENT A REVISION PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. POLY WEAR WAS INDICATED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO THE HOSPITAL CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.
Patient problems: Pain
MAUDE report 25526241 ↗InjuryJun 12, 2026Naturally Worn
AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.
Patient problems: Osteolysis
MAUDE report 25486078 ↗InjuryJun 9, 2026Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT THA, PRESENTED WITH COMPLAINTS OF PAIN AND UNDERWENT A REVISION PROCEDURE. THE REPORT STATED THE COATING CAME OFF OF THE CUP. THE LINER AND CROWN CUP WERE REVISED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Patient problems: Pain
MAUDE report 25451589 ↗InjuryJun 9, 2026Peeled/Delaminated
IT WAS REPORTED THAT A PATIENT, WHO HAD A LEFT THA, PRESENTED WITH COMPLAINTS OF PAIN AND UNDERWENT A REVISION PROCEDURE. THE REPORT STATED THE COATING CAME OFF OF THE CUP. THE LINER AND CROWN CUP WERE REVISED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.
Patient problems: Pain
MAUDE report 25451517 ↗
Other Exactech, Inc. products
- Equinoxe305 models · 2,076 reports · 37 recalls
- Optetrak Logic408 models · 3,306 reports · 3 recalls
- Optetrak336 models · 1,773 reports · 6 recalls
- Truliant414 models · 1,010 reports · 2 recalls
- Acumatch A Series94 models · 54 reports · 15 recalls
- MCS25 models · 7 reports · 5 recalls
- Alteon135 models · 100 reports · 3 recalls
- Vantage66 models · 110 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page