OptetrakRecalls & reported problems across all models
Exactech, Inc. · 336 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
6 open recalls name at least one Optetrak model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,773
- Deaths reported
- 0
- Injuries reported
- 1,768
- Recalls
- 6
We found 336 models of Optetrak by Exactech, Inc. in the FDA's device registry (GUDID). Together they are named in 1,773 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2018 and Sep 30, 2026 — classified as 1,768 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (1,119 reports).
6 FDA recall records name at least one of these models by its device identifier, 6 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
Optetrak 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.
- Apr 18, 2024Open, Classified
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Z-2158-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
- Apr 18, 2024Open, Classified
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Z-2157-2024 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Apr 18, 2024Open, Classified
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Z-2156-2024 · Root cause: Under Investigation by firm · names 6 of these models · Recall details · FDA record ↗
- Apr 18, 2024Open, Classified
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Z-2155-2024 · Root cause: Under Investigation by firm · names 6 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-0582-2024 · Root cause: Packaging change control · names 14 of these models · Recall details · FDA record ↗
- Aug 30, 2021Open, Classified
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Z-0019-2022 · Root cause: Process control · names 227 of these models · Recall details · FDA record ↗
Most reported Optetrak problems
Device problems
- Naturally Worn1,119
- Loosening of Implant Not Related to Bone-Ingrowth410
- Adverse Event Without Identified Device or Use Problem331
- Unstable287
- Insufficient Device Problem Information129
- Fracture64
- Mechanical Problem29
- Detachment of Device or Device Component21
Patient problems
- Failure of Implant701
- Pain623
- Osteolysis580
- Synovitis405
- Joint Laxity385
- Swelling/ Edema300
- Insufficient Information296
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available256
Optetrak models
336 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Optetrak 200-02-35Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls131 reports
- Optetrak 200-02-32Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls122 reports
- Optetrak 200-02-38Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls100 reports
- Optetrak 200-02-29Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls50 reports
- Optetrak 200-02-41Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls33 reports
- Optetrak 200-07-32Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls26 reports
- Optetrak 200-07-35Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls13 reports
- Optetrak 200-07-29Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls12 reports
- Optetrak 208-23-18Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls11 reports
- Optetrak 200-03-32Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls9 reports
- Optetrak 200-02-26Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls8 reports
- Optetrak 208-24-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls6 reports
- Optetrak 204-21-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls1 report
- Optetrak 204-22-26Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls0 reports
- Optetrak 204-24-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall38 reports
- Optetrak 204-23-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall37 reports
- Optetrak 204-23-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall26 reports
- Optetrak 204-24-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall25 reports
- Optetrak 204-22-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall21 reports
- Optetrak 204-22-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall19 reports
- Optetrak 200-23-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall17 reports
- Optetrak 200-24-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall17 reports
- Optetrak 200-72-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall16 reports
- Optetrak 208-22-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall16 reports
- Optetrak 208-22-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall15 reports
- Optetrak 204-24-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall14 reports
- Optetrak 204-22-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall13 reports
- Optetrak 204-25-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall13 reports
- Optetrak 200-62-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak 208-22-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall12 reports
- Optetrak 208-22-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak 244-24-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak 244-25-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall11 reports
- Optetrak 200-23-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak 204-23-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak 208-23-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak 244-23-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 reports
- Optetrak 200-05-26Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak 204-23-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak 208-24-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak 208-25-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak 244-23-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak 244-24-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall9 reports
- Optetrak 200-22-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 200-72-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 204-24-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 204-25-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 208-23-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 208-23-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 244-22-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall8 reports
- Optetrak 200-22-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak 200-22-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak 208-22-18Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak 208-24-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak 208-24-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak 208-25-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall7 reports
- Optetrak 200-24-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 200-63-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 200-64-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 200-73-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 200-73-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 200-75-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 208-23-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 208-25-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 244-22-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 244-23-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall6 reports
- Optetrak 200-03-35Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 200-23-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 200-62-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 200-63-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 200-74-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 204-21-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 204-22-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 208-25-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 244-22-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall5 reports
- Optetrak 200-05-29Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 200-21-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 204-13-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 204-21-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 204-26-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 208-24-18Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 208-25-18Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 200-23-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 200-24-13Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 200-25-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 200-64-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 200-65-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 200-74-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 204-22-18Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 204-24-18Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 204-26-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 208-21-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 208-22-22Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 244-25-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak 200-05-23Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 200-21-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 200-22-15Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 200-25-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 200-51-09Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 200-62-11Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
Recent Optetrak adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Naturally Worn
Report #2 of 2 for this event.As reported, this patient had an initial right total knee arthroplasty. Subsequently, four (4) years, ten (10) months later the patient underwent a revision due to polyethylene wear. The patella and tibial insert components were revised. The patient was last known to be in stable condition following the event. No additional information is available.
Patient problems: Insufficient Information
MAUDE report 50947020 ↗InjurySep 24, 2026Naturally Worn
It was reported that the patient underwent a knee replacement utilizing an Optetrak CR Slope++ tibial insert. Subsequently, the patient experienced knee pain and swelling. The surgeon diagnosed wear of the tibial insert, and a revision procedure was performed. During the revision, damage and wear were observed on the retrieved tibial insert and tibial tray. As a result, the tibial insert, tibial tray, and femoral component were explanted and replaced with an Activit-E PSC Size 1, 15 mm insert, a Size 1F/1T tibial tray, and a Logic Femoral Component Size 1 Right. Additional implants utilized during the procedure included a 14 mm × 80 mm stem extension, two Size 1T 5 mm tibial augments, a Size 1 5 mm posterior femoral augment, a Size 1 10 mm femoral augment, and a Size 1 5 mm distal femoral augment. The patient outcome was not further reported.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50881081 ↗InjuryAug 27, 2026Naturally Worn
Report #3 of 3 for this event.It was reported this patient underwent bilateral total knee arthroplasties. Subsequently four (4) years, eight (8) months later, the patient experienced pain and lysis of the right knee. As a result, the patient underwent a right knee revision procedure due to polyethylene wear and lysis secondary to a recalled polyethylene insert and femoral loosening. An operative report was provided. Intraoperatively, synovitis was observed. The patella was significantly damaged, linear wear markings on the articular surface of the tibial insert and the femoral was removed cleanly with no attachment. The patient was awoken from anesthesia and transferred to the recovery room in stable condition.Additionally, it is reported via legal documentation this patient alleges experiencing significant pain and discomfort, stiffness, gait impairment, difficulty walking, difficulty ascending and descending stairs, inflammation, swelling and other injuries presently undiagnosed.
Patient problems: Ambulation or Postural Difficulties; Osteolysis; Pain; Synovitis
MAUDE report 50484727 ↗InjuryAug 18, 2026Naturally Worn
It was reported that this patient underwent a right knee replacement. Subsequently, the tibial insert and patellar polyethylene components were revised due to wear. The patellar polyethylene demonstrated significant wear with mild associated osteolysis; however, no bone grafting was required. The tibial insert also demonstrated moderate wear. The patient was last known to be in stable condition following the event. No further information is available.
Patient problems: Osteolysis
MAUDE report 50305571 ↗InjuryAug 18, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth
Report #2 of 2 for this event.It was reported via legal notification this patient, underwent an initial left total knee arthroplasty. Subsequently, then (10) years, three (3) months later, the patient experienced pain, swelling, instability, and bone loss of the left knee. As a result, the patient underwent a revision surgery. An operative report was provided. Post operative diagnosis noted mechanical loosening of internal left knee prosthetic joint and polyethylene wear of left knee joint prosthesis. Intraoperatively, the tibial component was noted to be loose. The patient was awoken and taken to the recovery room in stable condition.
Patient problems: Ambulation or Postural Difficulties; Erosion; Joint Laxity; Pain; Swelling/ Edema
MAUDE report 50301361 ↗InjuryAug 11, 2026Naturally Worn
It was reported patient had an initial left total knee arthroplasty. Subsequently, eleven (11) years nine (9) months later, the patient was revised due to polyethylene flaking and delamination. The patella and tibial insert components were replaced. Patient was last known to be in stable condition following the event.(b)(6) 204-24-09 Tibial Insert Posterior Stabilized SZ 4, 9mm ***Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that DOES NOT contain EVOH. 510k: K933610 UDI:(b)(4). CONCOMITANTS: 2025330 204-04-45 Tibial tray trapezoid, cemented. 2232579 234-02-04 Asymmetric femoral posterior stabilized, cemented SZ 4 LEFT. 2228270 200-02-32 3 Peg Patella, cemented 32mm.
Patient problems: Insufficient Information
MAUDE report 50212473 ↗InjuryAug 11, 2026Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth
Report #3 of 3 for this event.It was reported this patient had an initial right total knee arthroplasty. Subsequently, fourteen (14) years, ten (10) months later, the patient began experiencing worsening symptoms, pain, instability, effusion, and antalgic gate. As a result, the patient required a right total knee revision procedure. An operative report was provided. The patient was revised due to periprosthetic osteolysis of the right knee joint. Intraoperatively, there was significant effusion and synovitis. The tibial insert showed delamination with no evidence of loosening. The femoral component was debonded and removed without significant bone loss. The patella was worn and loose. The patient was revised to another manufacturer's construct. The patient tolerated the procedure well and was transferred to the recovery room in stable condition.Additionally, it was reported via legal documentation the patient continues to experience pain and discomfort on a daily basis in both knees which limits daily activities and quality of life. No further information was reported.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis
MAUDE report 50208062 ↗InjuryAug 11, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Joint effusion; Osteolysis; Pain; Swelling/ Edema; Synovitis
MAUDE report 50207815 ↗InjuryAug 10, 2026Naturally Worn
As reported, approximately 6 years and 4 months post the initial left total knee arthroplasty, the patient was revised due to wear of the tibial and patellar polys. The patella poly showed moderate wear with mild osteolysis of the bone; no bone graft required. There was minimal wear on the tibial insert. 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: Osteolysis
MAUDE report 50193804 ↗InjuryAug 10, 2026Naturally Worn
It was reported that the patient underwent an initial left total knee arthroplasty. Subsequently, it was reported that the patient experienced pain, swelling and prosthesis wear. As a result, the patient underwent a left knee revision approximately 1 year and 6 months after initial implantation. During the revision it was noted that the femoral component was loose. The patient was transferred to the recovery room in stable condition. No further information available.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis
MAUDE report 50189477 ↗InjuryAug 6, 2026Unstable; Naturally Worn
As reported, approximately 20 years and 7 months post the initial right total knee arthroplasty, the patient was revised due to poly wear over time. 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: Joint Laxity
MAUDE report 50158249 ↗InjuryAug 4, 2026Fracture; Naturally Worn
It was reported that this patient underwent a right knee replacement. Subsequently, the patient reported pain. The tibial insert and patellar component are subject to the recall. Evaluation also identified a loose femoral component. The patient was last known to be in stable condition following the event. No further information is available.
Patient problems: Pain
MAUDE report 50127238 ↗InjuryAug 3, 2026Naturally Worn
As reported, approximately 10 years and 4 months post the initial right total knee arthroplasty, the patient was revised due to tibial and patellar wear. The patella poly showed significant wear with mild osteolysis of the bone; no bone graft required. There was moderate wear on the tibial insert. 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: Osteolysis
MAUDE report 50113608 ↗InjuryJul 28, 2026Naturally Worn
According to the information provided, the patient underwent a left total knee replacement surgery. Approximately 12 years and 11 months later, the patient had revision surgery on the left knee. All components were removed. Per the Operative Report, the patient presented with significant mechanical loosening and instability of their left primary total knee prosthesis. This was refractory to comprehensive nonoperative management due to extensive polyethylene wear and osteolysis. Because the patient has filed a long form, it appears that they are alleging prosthesis wear, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed.
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis
MAUDE report 50058395 ↗InjuryJul 7, 2026Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED LAXITY, EFFUSION, PAIN, AMBULATION DIFFICULTIES AND SYNOVITIS. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Joint effusion; Pain; Synovitis
MAUDE report 25733278 ↗
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
- 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.
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