Optetrak 200-24-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885862040299), received between May 5, 2021 and Aug 26, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (16 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, 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 173 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEARTHE LEFT KNEE HAS NOT YET BEEN REVISED TO DATE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20063126 ↗
• InjuryAug 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 161 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE LINER WEAR RESULTING IN LARGE AMOUNTS OF OSTEOLYSIS WITHIN THE PROXIMAL MEDIAL AND LATERAL TIBIAL PLTEAU AND BONE LOSS ALONG THE POSTERIOR TIBIAL CORTEX. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 20047402 ↗
• InjuryAug 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 157 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, TISSUE AND BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20028595 ↗
• InjuryAug 21, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 179 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: Insufficient Information; Osteolysis

  MAUDE report 20016546 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 108 MONTHS AFTER A BILATERAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND OTHER UNSPECIFIED CAUSES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19263456 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  EMAIL TO COMPLAINTS - SPAIN UBARMIN #92 DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON 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. ON (B)(6) 2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 200-24-09 CR TIBIAL INSERT SZ4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2011. THE INSERT WAS MANUFACTURED ON 4/26/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/26/2010 AND WAS 0.89 YEARS OF SHELF AGE AT THE TIME OF IMPLANT. PATIENT WAS REVISED ON (B)(6) 2023 APPROXIMATELY 12.45 YEARS POST IMPLANT. MASSIVE LYSIS OF THE TIBIAL PLATEAU AND INTERNAL FEMORAL CONDYLE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18352784 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  (B)(6) #81 DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN PERSON 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. ON 28-NOV-2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS PATIENT (B)(6) WAS IMPLANTED WITH A 200-24-09 CR TIBIAL INSERT SZ4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2016. THE INSERT WAS MANUFACTURED ON 4/24/2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/24/2015 AND WAS 0.80 YEARS OF SHELF AGE AT THE TIME OF IMPLANT. PATIENT WAS REVISED ON (B)(6) 2023 APPROXIMATELY 7.47 YEARS POST IMPLANT. HE HAS TWO PRIMARY IMPLANTED PROSTHESES. THE LEFT ONE IS REPLACED AND THE RIGHT ONE IS IN GOOD CONDITION (IT HAS NO EVOH BAG). FEMUR DEFECT POSTERIOR CONDYLES AND BONE DEFECT IN TIBIA. J&J IS IMPLANTED WITH PODS. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Osteolysis

  MAUDE report 18352625 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  AS REPORTED, ON (B)(6) 2023 THIS PATIENT WAS IMPLANTED WITH A 200-24-09 CR TIBIAL INSERT SZ4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2016. THIS PATIENT IS PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME THE INSERT WAS MANUFACTURED ON 4/24/2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18346681 ↗
• InjuryDec 14, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, REPRESENTATIVES OF EXACTECH, INC. AND EXACTECH SPAIN CONDUCTED AN IN-PERSON 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. ON (B)(6) 2023 UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS 71 YEAR-OLD MALE PATIENT WAS IMPLANTED WITH A (CR TIBIAL INSERT SZ4, 9MM CAT# 200-24-09 / SERIAL# (B)(6) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 26-APR-2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS 2.73 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2022, APPROXIMATELY NINE YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. THERE WAS CLEAR SIGNS OF POLYETHYLENE WEAR. PATIENT WAS REVISED TO A COMPETITOR¿S DEVICE. .

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18332552 ↗
• InjuryOct 29, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2014. IN 2018, ASYMMETRY WAS OBSERVED IN THE POLY AND THERE WAS PAIN AND INFLAMMATION IN THE KNEE. IN 2020 THE PATIENT CONTINUED TO HAVE PAIN AND INFLAMMATION IN THE KNEE. THE PATIENT WAS REVISED ON (B)(6) 2021. NO PATIENT INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Implant Pain; Inflammation; Pain

  MAUDE report 18027232 ↗
• InjuryMay 24, 2023Naturally Worn; Naturally Worn

  IN 2019, THE PATIENT REPORTED STROKE AND PAIN. IN (B)(6) 2021, VERY DETERIORATED POLYETHYLENE WAS OBSERVED WITH CLEAR SYMPTOMS OF WEAR AND DEBRIS. RIGHT KNEE. "THE REVIEW PROCEEDS".

  Patient problems: Insufficient Information; Pain

  MAUDE report 16998481 ↗
• InjuryMay 23, 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 200-24-09-INSERTO TIBIAL CR 4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2014. THE INSERT WAS MANUFACTURED ON 3/26/2013 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 3/26/2013 AND WAS 1 YEAR SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2014, APPROXIMATELY 1.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16989323 ↗
• InjuryMay 23, 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 200-24-09-INSERTO TIBIAL CR 4, 9MM, SERIAL NUMBER (B)(6) ON (B)(6)2011. THE INSERT WAS MANUFACTURED ON 2/2/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 2/2/2010 AND WAS 1.5 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 11/1/2014, APPROXIMATELY 3.0 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16989111 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 1995. THE PATIENT COMPLAINED OF JOINT PAIN AND WAS REVISED ON (B)(6) 2023. THE PATIENT WAS REVISED TO TRULIANT CRC TIB INSERT SZ 4, 17MM, 02-022-51-4017. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16758737 ↗
• InjuryMar 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2012. THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE ON (B)(6) 2017 SECONDARY TO POLYETHYLENE LINER WEAR RESULTING IN EXTENSIVE OSTEOLYSIS, SYNOVITIS, AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT KNEE ON (B)(6) 2021 SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. FIRST REVISION REPORTED UNDER 1038671-2023-00528.

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

  MAUDE report 16633022 ↗
• InjuryMar 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2012. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 SECONDARY TO POLYETHYLENE LINER WEAR RESULTING IN EXTENSIVE OSTEOLYSIS, SYNOVITIS, AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Cyst(s); Discomfort; Distress; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 16632994 ↗
• InjuryMay 5, 2021Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 MONTHS POSTOP THE INITIAL RIGHT TKA, THE RIGHT KNEE WAS REVISED DUE TO KNEE INSTABILITY. ON EXAMINATION INCREASE POLY WEAR WAS FOUND, NEW 9MM CR NEUTRAL INSERT WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 11778862 ↗

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