Acumatch A SeriesRecalls & reported problems across all models
Exactech, Inc. · 94 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
14 open recalls name at least one Acumatch A Series model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls
- 15
We found 94 models of Acumatch A Series by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2019 and May 13, 2026 — classified as 54 injuries.
The most frequently reported specific device problem is “Naturally Worn” (34 reports).
15 FDA recall records name at least one of these models by its device identifier, 14 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
Acumatch A Series 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.
- 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-1734-2022 · Root cause: Process control · names 31 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-1728-2022 · Root cause: Process control · names 40 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-1727-2022 · 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-1726-2022 · Root cause: Process control · names 2 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-1725-2022 · Root cause: Process control · names 6 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 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-2132-2021 · 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-2131-2021 · Root cause: Unknown/Undetermined by firm · names 6 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-2124-2021 · Root cause: Unknown/Undetermined by firm · names 6 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 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-2121-2021 · Root cause: Unknown/Undetermined by firm · names 7 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 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-2117-2021 · 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-2116-2021 · Root cause: Unknown/Undetermined by firm · names 6 of these models · 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-1031-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Acumatch A Series problems
Device problems
- Naturally Worn34
- Adverse Event Without Identified Device or Use Problem12
- Loosening of Implant Not Related to Bone-Ingrowth6
- Unstable4
- Device Dislodged or Dislocated3
- Insufficient Device Problem Information3
- Appropriate Device Problem Term/Code Not Available1
- Biocompatibility1
Patient problems
- Failure of Implant34
- Osteolysis12
- Pain12
- Joint Dislocation7
- Insufficient Information6
- Joint Laxity5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Discomfort2
Acumatch A Series models
94 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Acumatch A Series 138-36-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Acumatch A Series 132-36-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls7 reports
- Acumatch A Series 132-32-27Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls6 reports
- Acumatch A Series 132-28-25Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls4 reports
- Acumatch A Series 138-36-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls4 reports
- Acumatch A Series 132-32-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls3 reports
- Acumatch A Series 130-32-27Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Acumatch A Series 132-28-24Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Acumatch A Series 132-28-27Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Acumatch A Series 132-36-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Acumatch A Series 138-28-27Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls2 reports
- Acumatch A Series 132-28-26Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls1 report
- Acumatch A Series 132-28-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls1 report
- Acumatch A Series 130-28-25Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-28-26Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-28-27Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-28-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-28-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-32-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-32-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-36-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-36-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 130-36-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 132-28-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 132-28-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 132-32-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 132-32-30Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 recalls0 reports
- Acumatch A Series 132-36-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 134-28-25Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 134-28-26Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 134-28-27Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 134-28-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 134-28-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 134-28-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 138-28-25Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 138-28-26Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 138-28-28Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 138-28-29Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 138-36-27Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls0 reports
- Acumatch A Series 138-36-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls0 reports
- Acumatch A Series 132-28-06Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall5 reports
- Acumatch A Series 132-32-07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall2 reports
- Acumatch A Series 130-28-08Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall1 report
- Acumatch A Series 132-28-07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall1 report
- Acumatch A Series 138-28-08Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall1 report
- Acumatch A Series 130-28-05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 130-28-06Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 130-28-07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Acumatch A Series 130-28-09Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 130-28-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 130-32-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 132-22-03Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 132-22-04Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-22-05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-22-06Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-22-07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-22-08Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-28-04Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 132-28-05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-28-08Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-28-09Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-28-10Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-32-08Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-32-09Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-32-10Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 132-36-08Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 132-36-09Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 132-36-10Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 132-36-27Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented1 recall0 reports
- Acumatch A Series 134-28-05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 134-28-06Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 134-28-07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 134-28-08Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 134-28-09Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 134-28-10Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 138-28-05Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 138-28-06Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 138-28-07Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 138-28-09Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 recall0 reports
- Acumatch A Series 138-28-30Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 138-36-08Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 138-36-09Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 recall0 reports
- Acumatch A Series 144-32-05Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Acumatch A Series 144-32-06Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Acumatch A Series 144-32-07Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Acumatch A Series 144-32-08Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Acumatch A Series 144-32-09Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Acumatch A Series 144-32-10Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer1 recall0 reports
- Acumatch A Series 120-01-50Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2 reports
- Acumatch A Series 120-01-44Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Acumatch A Series 120-01-52Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Acumatch A Series 120-01-54Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Acumatch A Series 120-01-60Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
- Acumatch A Series 120-01-62Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1 report
Recent Acumatch A Series adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026Loss of Osseointegration
IT WAS REPORTED VIA LEGAL THAT 13 YEARS POST OP THE INITIAL RIGHT THA, THIS FEMALE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS, POLY WEAR AND PERIPROSTHETIC FRACTURE. PATIENT WAS HAVING PAIN AND X-RAY REVEALED ACTEBULAR POLY WEAR AND OSTEOLYSIS. SURGEON PERFORMED A REVISION OF THE RIGHT ACETABULAR COMPONENTS AND FEMORAL HEAD. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Aseptic loosening; Osteolysis; Pain; Periprosthetic fracture
MAUDE report 25165314 ↗InjuryMay 4, 2026Naturally Worn
IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. OVER TIME, THE POLYETHYLENE COMPONENT EXHIBITED WEAR, AND THE PATIENT EXPERIENCED ASSOCIATED PAIN. A REVISION PROCEDURE WAS PERFORMED. THE FEMORAL STEM WAS ASSESSED INTRAOPERATIVELY AND FOUND TO BE STABLE AND WELL-FIXED; THEREFORE, IT WAS RETAINED. THE PATIENT WAS REVISED TO AN EXACTECH BIOLOX OPTION FEMORAL HEAD AND ADAPTER. THE ACETABULAR LINER WAS EXCHANGED TO A COMPETITOR¿S DEVICE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 25071705 ↗InjuryFeb 3, 2026Device Dislodged or Dislocated; Naturally Worn
IT WAS REPORTED THAT A PATIENT, WHO HAD A THA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 19 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO EXPECTED WEAR AND REPORTS OF DISLOCATION. THE HEAD LINER WAS EXCHANGED. IT WAS STATED THERE WERE NO ISSUES WITH THE SURGERY. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. AN X-RAY WAS PROVIDED. NO FURTHER INFORMATION.
Patient problems: Joint Dislocation
MAUDE report 24251567 ↗InjurySep 18, 2025Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 20 YEARS AND 6 MONTHS POST THE INITIAL TOTAL HIP REPLACEMENT, THE PATIENT WAS REVISED DUE TO PAIN AND WEAR. THE PATIENT WAS CONVERTED TO A COMPETITOR CUP AND DUAL MOBILITY LINER. A NEW EXACTECH HEAD WAS PLACED. THERE WERE NO ISSUES WITH THE SURGERY. NO FURTHER INFORMATION PROVIDED.
Patient problems: Pain
MAUDE report 23083103 ↗InjuryJan 28, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY FOR ARTHRITIS ON (B)(6) 2009 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON(B)(6) 2016 APPROXIMATELY 7 YEARS AND 4 MONTHS AFTER INITIAL IMPLANT. PATIENT HAS EXPERIENCED THE FOLLOWING INJURIES INCLUDING SIGNIFICANT PAIN, AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, PROTHESIS WEAR, SOFT TISSUE DAMAGE, AND BONE LOSS. PATIENT WAS REVISED TO COMPETITOR'S DEVICES/ POSTOPERATIVE DIAGNOSIS: LEFT HIP FAILED HIP. PATIENT PRESENTED TO THE SURGEON WITH PAIN AND RADIOGRAPHIC AND CLINICAL EVIDENCE OF ACETABULAR COMPONENT FAILURE. THE FEMUR WAS IDENTIFIED AND EXAMINED AND REVEALED A WELL-FIXED FEMORAL COMPONENT. THE ACETABULUM WAS INSPECTED AND DID APPEAR TO HAVE SIGNIFICANT ACETABULAR BONE LOSS TO THE PUBIS, ISCHIUM AND SUPERIOR DOME WITH GROSS DISTORTION OF THE HEMISPHERE. FINDINGS: LEFT HIP WITH SEVERE ACETABULAR BONE LOSS PAPROSKY GRADE 2, GROSSLY LOOSE ACETABULAR COMPONENT. THERE WERE NO INTRAOPERATIVE COMPLICATIONS, THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THE PATIENT PASSED AWAY ON (B)(6) 2022, THOUGH IT IS NOT INDICATED OR SUGGE
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain
MAUDE report 21257544 ↗InjuryNov 19, 2024Naturally Worn; Naturally Worn
AS REPORTED, APPROXIMATELY 15 YEARS 8 MONTHS POST OP INITIAL LEFT THA, THIS 51 Y/O FEMALE PATIENT WAS REVISED. HEAD WORE THROUGH THE LINER AND THE CUP. CUP NEEDED TO BE REMOVED. PATIENT HAD A HIP DONE IN 2008 WITH M SERIES STEAM ND ACUMATCH CUP. USED COMPETITORS DEVICE REVISION CUP AND EXACTECH HEAD. PATIENT WAS LAST KNOW TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS OR X-RAYS. PRODUCT NOT RETURNING - HOSPITAL WON'T RELEASE.
Patient problems: Insufficient Information
MAUDE report 20725533 ↗InjurySep 11, 2024Naturally Worn; Naturally Worn
LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4)). RELATED (B)(4) LH REV 1. (B)(4) LH REV 2. IT WAS REPORTED THAT APPROXIMATELY 166 MONTHS AFTER A TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE." (B)(6) 132-28-06 - ACUMATCH 15 DEGREE LINER 28MM SZ F. ***SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES CONTAIN EVOH AND WAS NOT AFFECTED BY THE RECALL.
Patient problems: Joint Laxity; Osteolysis; Pain; Swelling/ Edema
MAUDE report 20193831 ↗InjuryAug 21, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT APPROXIMATELY UNKNOWN MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Osteolysis; Pain
MAUDE report 20012238 ↗InjuryAug 15, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES.. FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.
Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology; Osteolysis; Scar Tissue; Synovitis
MAUDE report 19992766 ↗InjuryMay 30, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A HIP REVISION APPROXIMATELY 16 YEARS POST OP. REASON FOR THE REVISION WAS NOT REPORTED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 19424434 ↗InjuryMay 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THIS 86 Y/O FEMALE PATIENT'S LEFT HIP WAS REVISED. PATIENT HAD A DISSOCIATED CUP. STEM WAS LEFT IN, ONLY FEMORAL HEAD WAS REVISED TO EXACTECH. ACETABULAR SIDE WAS REVISED TO A COMPETITORS DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT . DEVICES ARE NOT RETURNING - HOSPITAL POLICY.
Patient problems: Failure of Implant
MAUDE report 19373914 ↗InjuryMay 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL LEFT THA, THE 75 Y/O FEMALE PATIENT HAD A REVISION AND THE CUP/HEAD WERE REMOVED. PATIENT'S WAS REVISED ONLY TO EXACTECH FEMORAL HEAD 36MM +10, BUT ACETABULAR COMPONENTS WERE REVISED TO COMPETITOR'S DEVICES. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.
Patient problems: Failure of Implant
MAUDE report 19274846 ↗InjuryApr 19, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ON (B)(6) 2020 AND WAS REVISED ON (B)(6) 2022. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE PROSTHESIS WEAR, PAIN, COMPONENT LOOSENING AND DEVICE FAILURE. THE MOSTLY LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1728-2022 (B)(6) 132-36-29 - ACUMATCH GXL 15DEG LINER 36MM SZ J 510K: K051556 UDI: (B)(4). CONCOMITANT DEVICES: 5834507 100-36-00 - 36MM +0MM FEMORAL HEAD. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1728-2022. SERIAL: (B)(6). 132-36-29 - ACUMATCH GXL 15DEG LINER 36MM SZ J 510K: K051556 UDI: (B)(4).
Patient problems: Failure of Implant
MAUDE report 19148056 ↗InjuryApr 1, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2020 APPROXIMATELY 12 YEARS AND 7 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 19011102 ↗InjuryApr 1, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2011 APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 19011095 ↗
Other Exactech, Inc. products
- Equinoxe305 models · 2,076 reports · 37 recalls
- Optetrak Logic408 models · 3,306 reports · 3 recalls
- Novation184 models · 1,145 reports · 25 recalls
- Optetrak336 models · 1,773 reports · 6 recalls
- Truliant414 models · 1,010 reports · 2 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.
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