Optetrak 200-23-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862040251), received between Sep 13, 2022 and May 19, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT REQUIRED A REVISION SURGERY DUE TO PAIN AND OSTEOLYSIS. THE PATIENT TOLERATED THE PROCEDURES WELL WITH NO REPORTED COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 25225325 ↗
• InjuryMay 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 67 YO FEMALE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY 12 YEARS 6 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON INDICATED THE PATIENT REQUIRED A POLY SWAP. ON THE DAY OF SURGERY, UPON EXPLANTATION, THE CR POLY WAS REMOVED AND FOUND TO HAVE MEDIAL WEAR AND DELAMINATION. THE PATIENT HAS BILATERAL CR KNEES AND BOTH KNEES HAVE LINERS AND PATELLAS ON THE RECALL LIST. DOCTOR WAS INFORMED AND PATELLA WAS ALSO REMOVED. CRC LINER WAS REIMPLANTED ALONG WITH PATELLA. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE EVENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE AS THE HOSPITAL WILL NOT RELEASE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22014981 ↗
• InjuryJan 7, 2025Naturally Worn; Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2014. THE PATIENT WAS REVISED APPROXIMATELY 8 YEARS AND 2 MONTHS LATER ON (B)(6) 2022. JOINT FLUID WAS OBTAINED AND SENT FOR CULTURE AND SENSITIVITY X3. EXTENSIVE SYNOVITIS FROM THE POLYETHYLENE WAS NOTED. THE FEMORAL COMPONENT WAS GROSSLY LOOSE AND WAS REMOVED WITH OSTEOTOMES. THE TIBIAL COMPONENT AND PATELLA WERE ALSO GROSSLY LOOSE AND WERE REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Synovitis

  MAUDE report 21095806 ↗
• InjuryAug 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 186 MONTHS AFTER A RIGHT 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

  MAUDE report 20002484 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL THA ON AN UNKNOWN DATE. THE PATIENT IS PENDING REVISION SURGERY; REASON UNKNOWN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19085445 ↗
• InjuryNov 27, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6)2010. APPROXIMATELY 3 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2013. 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) 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 OF WEAR OF AN EXA

  Patient problems: Insufficient Information

  MAUDE report 18208907 ↗
• InjuryMay 18, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(4), 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 200-23-11-INSERTO TIB CR 3, 11MM, SERIAL NUMBER (B)(6)ON (B)(4) 2014. THE INSERT WAS MANUFACTURED ON 7/13/2010 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 7/13/2010 AND WAS 3.8329911019849416 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(4) 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: Failure of Implant; Insufficient Information

  MAUDE report 16954965 ↗
• 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 200-23-11-INSERTO TIB CR 3, 11MM, 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 1.0403832991101984 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 16952908 ↗
• InjuryOct 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL NOTIFICATION THAT AN 85 YO FEMALE PATIENT, HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2009, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014, APPROXIMATELY 5 YEARS POST OP FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15534100 ↗
• InjurySep 13, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A RIGHT KNEE IMPLANTED ON AN UNKNOWN DATE, UNDERWENT A REVISION DUE TO EXCESSIVE WEAR TO THE IMPLANTS ON (B)(6) 2022. THE PATIENT WAS SUCCESSFULLY REVISED TO TRULIANT TIBIAL COMPONENTS UTILIZING TIBIAL AUGMENT BLOCKS AND CRC LINER. ALSO SUCCESSFULLY REVISED PATELLA. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE AVAILABLE FOR RETURN. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414090 ↗

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