Optetrak 200-22-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862040206), received between Sep 1, 2022 and May 10, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, 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.

• InjuryMay 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 112 MONTHS AFTER A RIGHT 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 19292632 ↗
• InjuryNov 9, 2023Naturally Worn; Naturally Worn

  THIS 71 Y/O, FEMALE PATIENT UNDERWENT INITIAL TKA OF THE RIGHT KNEE ON (B)(6) 2015 AND WAS IMPLANTED WITH A CR INSERT TIBIAL SIZE 2, 11MM (CN: 200-22-11, SN: (B)(6). ON (B)(6) 2021 THE PATIENT¿S RIGHT KNEE WAS REVISED DUE TO UNKNOWN REASONS. DURING THE REVISION, CLEAR ASYMMETRY OF THE POLYETHYLENE CAUSED BY WEAR WAS NOTED. IT WAS DECIDED TO DO THE REVISION IN 2 STAGES. DURING THIS FIRST STAGE A CEMENT SPACER (ONLY) WAS PLACED. LATER ON (B)(6) 2021, THE PATIENT UNDERWENT THE SECOND STAGE OF THE REVISION. AT THIS TIME, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT OSTEOLYSIS AND BONE LOSS IN THE TIBIA AND BOTH CONDYLES. THE SURGEON FELT THAT THIS WAS RELATED TO ASYMMETRICAL WEAR OF THE POLYETHYLENE INSERT. THE PATIENT WAS REVISED TO A JOHNSON & JOHNSON SIGMA TKA SYSTEM WITH ¿SLEEVES".

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 18106961 ↗
• InjurySep 8, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2010. THEY SUBSEQUENTLY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2022, APPROXIMATELY 12 YEARS 7 MONTHS POST PRIMARY PROCEDURE. REVISION OP REPORT STATES THAT "THERE WAS CLEAR EVIDENCE OF POLY WEAR AND DEBRIS" AND THAT "THE TIBIAL INSERT DEMONSTRATED EVIDENCE OF OXIDATION AND FAILURE." BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE DETERMINED TO BE SATISFACTORILY FIXED. 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: Failure of Implant; Synovitis

  MAUDE report 17712533 ↗
• InjuryMay 24, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(6), REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH (B)(6) 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 200-22-11-INSERTO TIB CR 2, 11MM, SERIAL NUMBER (B)(6) ON (B)(6)2014. THE INSERT WAS MANUFACTURED ON 1/27/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 1/27/2014 AND WAS 0.78 YEARS SHELF AGE AT THE TIME OF IMPLANT. THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE ON AN UNKNOWN DATE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16999698 ↗
• InjuryMay 23, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(6), REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN INPERSON SITE VISIT WITH (B)(6) 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 200-22-11-INSERTO TIB CR 2, 11MM, SERIAL NUMBER (B)(6) ON (B)(6)2014. THE INSERT WAS MANUFACTURED ON 2/25/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 2/25/2014 AND WAS 0.40520191649555098 YEARS SHELF AGE AT THE TIME OF IMPLANT. PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16989012 ↗
• InjuryOct 5, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS FEMALE PATIENT'S RIGHT KNEE WAS REVISED 10 YEARS POST OP DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. PATIENT HAD LOOSE COMPONENTS AND OSTEOLYSIS. FOLLOWING THE REVISION SURGERY, PLAINTIFF CONTINUES TO BE LIMITED IN HER ACTIVITIES OF DAILY LIVING. DESPITE UNDERGOING REVISION SURGERY, PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HER RIGHT KNEE WHICH LIMITS HER ACTIVITIES OF DAILY LIVING AND IMPACTS HER QUALITY OF LIFE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15545512 ↗
• InjurySep 1, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL, THAT THIS PATIENT'S RIGHT KNEE WAS IMPLANTED (B)(6) 2009. REVISION DATE: (B)(6) 2015; REASON FOR THE REVISION WAS NOT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15334331 ↗

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