Optetrak 200-22-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862040213), received between Jul 7, 2022 and Feb 18, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL LEFT KNEE ARTHROPLASTY AND THEN EXPERIENCED A SURGICAL REVISION APPROXIMATELY 8 YEARS, 7 MONTHS AFTER IMPLANT. REVISION OPERATIVE REPORT OF POSTOPERATIVE DIAGNOSIS: FAILED LEFT KNEE. PREOP INDICATION: FAILED LEFT PRIMARY KNEE, WITH GROSS LOOSENING OF THE TIBIAL COMPONENT TO PERIPROSTHETIC FRACTURE. PATIENT WAS REVISED TO STRYKER DEVICES. FINDINGS: NEGATIVE FOR ACUTE INFLAMMATION BUT PERIPROSTHETIC FRACTURE TO THE TIBIA WITH ANTERIOR PERFORATION AND SIGNIFICANT POSTERIOR BONE LOSS ON THE TIBIA. SIGNIFICANT POLYETHYLENE WEAR AND GROSS FAILURE OF THE TIBIAL COMPONENT WITH POSTERIOR AND VARUS CLAP WITH PERFORATION AND PERIPROSTHETIC FRACTURES THROUGH THE MEDIAL TIBIAL PLATEAU. FEMORAL COMPONENT WAS SLIGHTLY INTERNALLY ROTATED. THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO IMMEDIATE COMPLICATIONS. (OP REPORT ATTACHED). THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Scar Tissue

  MAUDE report 21398474 ↗
• InjuryNov 12, 2024Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 12 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION AND ANOTHER COMPETITOR'S IMPLANT IN. THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. THE PATIENT EXPERIENCED PAIN AND SYNOVITIS. DURING THE REVISION THE SURGEON NOTED THAT THE "PROCEDURE WAS AT LEAST 50% MORE DIFFICULT AND COMPLEX DUE TO THE MASSIVE SYNOVITIS THAT WAS ENCOUNTERED AS WELL AS THE EXCESSIVE CEMENT THAT HAD TO BE REMOVED AND EXTRA BONY CUTS NECESSARY FOR THE AUGMENT ON THE TIBIAL SIDE.¿

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Synovitis

  MAUDE report 20662898 ↗
• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 120 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Depression; Failure of Implant; Implant Pain

  MAUDE report 19291682 ↗
• InjuryMay 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 93 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, TISSUE LOSS, BONE LOSS AND PREMATURE AND UNNECESSARY REVISION SURGERY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 19273791 ↗
• InjuryMay 19, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH UBARMIN HOSPITAL. AS A RESULT OF THAT SITE VISIT AND AT EXACTECH'S REQUEST, THE HOSPITAL PROVIDED A RETROSPECTIVE EXCEL LISTING OF REVISION RELATED TO POLYETHYLENE WEAR THAT HAVE BEEN PERFORMED SINCE 2010. THESE CASES HAVE NOT PREVIOUSLY BEEN REPORTED TO EXACTECH AS COMPLAINTS. THIS PATIENT (B)(6), WAS IMPLANTED WITH A 200-22-13-INSERTO TIB CR 2, 13MM, SERIAL NUMBER (B)(6), ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON (B)(6) 2013 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2013 AND WAS 1.43 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2023, APPROXIMATELY 11.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16962842 ↗
• InjuryOct 10, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THIRTEEN YEARS POST INITIAL TKA, PATIENT HAD A REVISION DUE TO PROSTHESIS WEAR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15571703 ↗
• InjuryJul 7, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A REVISION ON HER LEFT KNEE. REASON FOR THE REVISION WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 14943353 ↗

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