Optetrak 200-23-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885862040244), received between Oct 18, 2022 and Jun 24, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 52 YO MALE PATIENT WHO HAD A RIGHT KNEE IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 YEARS AND 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR WITH MASSIVE OSTEOLYSIS. ASSOCIATED WITH A PSEUDOTUMORAL LESION IN THE POPLITEAL AREA SECONDARY TO A FOREIGN BODY REACTION CAUSED BY POLYETHYLENE PARTICLES. THE PATIENT WAS REVISED TO A COMPETITOR¿S DEVICES. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Osteolysis

  MAUDE report 22319431 ↗
• InjurySep 16, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST OP. PATIENT WAS REVISED DUE TO WEAR AND PAIN. A NEW VIT E 9MM INSERT PLACED WITH NO ISSUES. EXPLANTS NOT AVAILABLE.

  Patient problems: Pain

  MAUDE report 20233585 ↗
• InjuryAug 23, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 137 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20052297 ↗
• InjuryDec 18, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, ON (B)(6) 2023 THIS PATIENT WAS IMPLANTED WITH A 200-23-09 CR TIBIAL INSERT SZ3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2011. PATIENT WAS REVISED ON (B)(6) 2022 DUE TO POLYETHYLENE WEAR. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME THE INSERT WAS MANUFACTURED ON 6/9/2010 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; Joint Laxity; Osteolysis; Pain

  MAUDE report 18347182 ↗
• 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 28-NOV-2023, UPDATES TO THE EXCEL LISTING WERE PROVIDED. THIS 57 Y/O MALE PATIENT WAS IMPLANTED WITH A OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM (CAT#: 200-23-09 / SERIAL#: (B)(6) ON (B)(6) 2008. THE INSERT WAS MANUFACTURED ON 3-OCT-2008 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS 0.04 YEARS OF SHELF AGE AT THE TIME OF IMPLANT. PATIENT WAS REVISED ON (B)(6) 2020 APPROXIMATELY 11.30 YEARS POST IMPLANT. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18332525 ↗
• InjuryNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 58 Y/O FEMALE PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST OP INITIAL TSA. IN (B)(6) 2014, THE TIBIAL PLATEAU WAS REPLACED AND THE PATELLA WAS IMPLANTED. REASON FOR THE REVISION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18103328 ↗
• InjuryNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 60 Y/O FEMALE PATIENT WAS REVISED IN APRIL 2016 FOR A SECOND TIME APPROXIMALY 2 YEARS POST OP FIRST REVISION (B)(4). THE FEMORAL COMPONENT WAS REPLACED WITH A CC FEMUR WITH WEDGES AND HF TIBIAL INSERT. REASON FOR THE REVISION WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 18101510 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD KNEE REPLACEMENT SURGERY ON (B)(6)2009. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2014, APPROXIMATELY 4 YEARS 4 MONTHS POST PRIMARY PROCEDURE. 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 COORDINATED ACTION IN (B)(6) COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18086550 ↗
• InjuryJun 16, 2023Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL LEFT TKA, THIS 63 Y/O FEMALE PATIENT WAS REVISED DUE TO POLY WEAR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING: HOSPITAL DISPOSED OF THEM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17144912 ↗
• InjuryMay 24, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL (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 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6)2014. THE INSERT WAS MANUFACTURED ON 2/20/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 2/20/2014 AND WAS 0.70 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 12/14/2022, APPROXIMATELY 8.0 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 16999277 ↗
• InjuryMay 21, 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. THIS PATIENT ((B)(6)) WAS IMPLANTED WITH A 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 13-JUN-2012 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 13-JUN-2012 AND WAS SEVEN MONTHS 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. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16971064 ↗
• InjuryMay 18, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, 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 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6)2013. THE INSERT WAS MANUFACTURED ON 9/28/2012 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 9/28/2012 AND WAS 0.39 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6)2021, APPROXIMATELY 8.0 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 16958396 ↗
• InjuryMay 18, 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 (284032) WAS IMPLANTED WITH A 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2015. THE INSERT WAS MANUFACTURED ON 4/19/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/19/2011 AND WAS 4.3942505133470222 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 2/15/2023, APPROXIMATELY 8.0 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 16955972 ↗
• InjuryMay 18, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL 17-25, 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 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 4/10/2012 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/10/2012 AND WAS 0.84052019164955505 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON 5/15/2019, APPROXIMATELY 6.0 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 16955924 ↗
• InjuryMay 18, 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 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6) 2015. THE INSERT WAS MANUFACTURED ON 3/12/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 3/12/2014 AND WAS 1.11 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: Failure of Implant; Insufficient Information

  MAUDE report 16954933 ↗
• InjuryMay 18, 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 200-23-09-INSERTO TIBIAL CR 3, 9MM, SERIAL NUMBER (B)(6) ON (B)(6)2015. THE INSERT WAS MANUFACTURED ON 5/7/2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 5/7/2015 AND WAS 0.55 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: Failure of Implant; Insufficient Information

  MAUDE report 16952783 ↗
• InjuryOct 18, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA IN 2008. THE PATIENT PRESENTED WITH PAIN AND WAS REVISED AND A NEW INSERT IMPLANTED. THE SURGEON NOTED SOME SYNOVITIS AND SOME POLY WEAR. 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; Synovitis

  MAUDE report 15624053 ↗

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