Optetrak 200-24-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862040305), received between Oct 20, 2022 and Apr 2, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K932776); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0019-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 11 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE. REVISION OPERATIVE REPORT ON (B)(6) 2023- LEFT KNEE REVISION ,POSTOPERATIVE DIAGNOSIS: MECHANICAL LOOSENING, POLYETHYLENE WEAR INDUCED OSTEOLYSIS.

  Patient problems: Cyst(s); Discomfort; Failure of Implant; Joint effusion; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 19029848 ↗
• InjuryMar 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6)2015, APPROXIMATELY 4 YEARS, 11 MONTHS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE 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; Discomfort; Failure of Implant; Pain

  MAUDE report 18859582 ↗
• InjuryNov 9, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS 56 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED. IN (B)(6) 2014, A CR WAS IMPLANTED IN THE RIGHT KNEE. IN 2018 THE PATIENT REPORTED DISCOMFORT. IN 2019, MOBILIZATION, ASYMMETRY AND INVOLVEMENT OF THE EXTERNAL TIBIAL PLATEAU WERE OBSERVED IN THE X-RAYS. IN 2019, THE REPLACEMENT WAS CARRIED OUT, OBSERVING SYNOVECTOMY, CYST IN THE INTERNAL CONDYLE, TIBIAL PLATEAUS WITH CYSTS AND TOTAL DESTRUCTION OF THE INTERNAL CONDYLE. PATIENT WAS REVISED WITH COMPETITORS DEVICE. IMAGES & X-RAYS NOT PROVIDED.

  Patient problems: Discomfort; Failure of Implant; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 18101203 ↗
• InjuryAug 29, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2009. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2017, APPROXIMATELY 7 YEARS 4 MONTHS POST PRIMARY PROCEDURE. THE PATIENT CLAIMS TO HAVE SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS AS A RESULT OF THIS EXACTECH DEVICE: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, INSTABILITY, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, APPLICATION OF WOUND VAC, AND REVISION WITH BONE GRAFT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 POLYETHYLEN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 17646663 ↗
• InjuryMay 23, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 62 Y/O MALE PATIENT HAD A LEFT KNEE REPLACEMENT (B)(6) 2009. APPROXIMATELY 12 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON 28 FEB 2022 DUE TO A FAILED TOTAL KNEE ARTHROPLASTY. REVISION OP REPORT REC'D ON 23 APR 2023: POLY WAS WORN WITHIN THE PATELLA. THERE WAS MODERATE PITTING BUT CONSIDERED NORMAL. NO TOTAL DESTRUCTION NOTED. NO EVIDENCE OF LOOSENING. NOTED TO BE A LARGE CYST BEHIND THE FEMUR. STERILE DRESSING WAS APPLIED. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN GOOD CONDITION. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16984737 ↗
• InjuryOct 20, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, PATIENT WAS REFERRED TO SEEK LEGAL REPRESENTATION FOR PAIN AND SUFFERING. PATIENT DOES NOT HAVE AN ATTORNEY AND WOULD TO AVOID HIRING ONE IF HIS CLAIM CAN BE SETTLED FAIRLY WITHOUT ONE. PATIENT HAD HIS INDEX SURGERY OF HIS LEFT KNEE ON (B)(6) 2010 AT THE AGE OF 46. HE HAD A LOT OF TROUBLE WITH IT ALMOST FROM DAY ONE. HIS ISSUE OF PAIN BECAME WORSE IN (B)(6) 2010. HE ALSO HAD DIFFICULTY WALKING. IN 2013 SURGEON TOLD HIM THAT HE WOULD NEED A REVISION DUE TO FAILURE OF THE IMPLANT. HIS LEFT KNEE REVISION WAS DONE SOMETIME IN 2014 WITH EXACTECH COMPONENTS. FIVE WEEKS LATER, HE HAD HIS RIGHT KNEE INDEX SURGERY. HE STATE HE HAS HAD NO PROBLEMS WITH HIS RIGHT KNEE WHATSOEVER. HE CONTINUED TO HAVE PROBLEMS WITH HIS LEFT KNEE. IN 2015 OR 2016 HE HAD FLUID REMOVED FROM ONE OF HIS KNEES WHILE IN THE OFFICE. HE THEN HAD AN ARTHROPLASTY DONE ON THAT SAME KNEE BUT IS UNSURE OF WHICH KNEE IT WAS. AT HIS MOST RECENT OFFICE VISIT WITH SURGEON, HE WAS TOLD THAT HE NOW HAS LEFT TIBIAL PLATE LOOSENING AS WELL AS POLYETHYLENE FAILURE AND WILL NEED ANOTHER REVISION.

  Patient problems: Ambulation or Postural Difficulties; Cyst(s); No Clinical Signs, Symptoms or Conditions; Osteolysis; Pain

  MAUDE report 15639272 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932776. One submission often covers many models, so check the product and lot details in each record.

• Z-0927-06 · Dec 19, 2005 · Terminated
  Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONL
• Z-1379-05 · Jun 2, 2005 · Terminated
  The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SING