Optetrak 208-22-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10885862054173), received between Nov 2, 2020 and Jan 24, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K954208); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6). (B)(4). ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 14-NOV-2023. 4 JAN 2024, V SIMMS, RN - IMPLANT DATE: (B)(6) 2016- REVISION OP REPORT ATTACHED. EXPLANT DATE: (B)(6) 2021, REVISION OP REPORT ATTACHED- THE DEVICES WERE IMPLANTED FOR APPROXIMATELY 4 YEARS, 6 MONTHS. POST OPERATIVE DIAGNOSIS: MECHANICAL LOOSENING. REVISION OF ALL COMPONENTS TO ZIMMER PERSONA REVISION SYSTEM. UPON OPENING THE KNEE JOINT, THE FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND THIS WAS EASILY EXTRACTED BY HAND. SIMILARLY, THE PATELLAR COMPONENT WAS TOTALLY LOOSE AND EASILY PRIED OFF OF THE REMAINING PATELLAR BONE STOCK. STERILE DRESSINGS WERE APPLIED AND THE PATIENT WAS EXTUBATED IN STABLE CONDITION. ORIGINAL DESCRIPTION SUMMARY AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 6 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD THE FIRST LEFT KNEE REVISION ON (B)(6) 2016. APPROXIMATELY 6 MONTHS AFTER THE FIRST LEFT KNEE REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2017. AFTER EACH OF THE LEFT TOTAL KNEE REPLACEMENT SURGERIES, THE PATIENT BEGAN TO SUFFER FROM SYMPTOMS, INCLUDI

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

  MAUDE report 21232434 ↗
• InjuryJan 14, 2025Naturally Worn; Naturally Worn

  LEGAL CASE-USA: PATIENT ID: (B)(6). REFER TO (B)(4) (B)(6). ADDITIONAL INFORMATION: SHORT FORM RECEIVED IN INBOX (B)(6) 2024. CLAIMS FROM SHORT FORM: PAIN, STIFFNESS, SWELLING, DISCOMFORT, AND WEAKNESS WHICH IN TURN NEGATIVELY AFFECTED PLAINTIFF'S MOBILITY AND QUALITY OF LIFE. AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2011. APPROXIMATELY 11 YEARS AND 11 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: RIGHT FAILED TOTAL KNEE. A THOROUGH SYNOVECTOMY WAS PERFORMED AND CULTURES WERE SENT. THE TIBIAL BASEPLATE WAS REMOVED REVEALING A LARGE UNCONTAINED DEFECT OF THE LATERAL TIBIAL PLATEAU. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. (B)(6) 2023, (B)(6), RN-FROM REVISION OP REPORT (B)(6) 2023- THE PATELLA WAS THEN DEBRIDED OF SCAR TISSUE AND THE BUTTON (WHICH WAS FRACTURED AND LOOSE ON EXPOSURE) WAS REMOVED WITH A SAW. PATELLAR RESURFACING W

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 21152465 ↗
• InjuryJan 8, 2025Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(6). CASE-(B)(4). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2008. APPROXIMATELY 14 YEARS AND 9 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. 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. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: MECHANICAL LOOSENING. EVALUATION OF THE KNEE DEMONSTRATED THE FEMUR WAS GROSSLY LOOSE AND WAS ABLE TO BE REMOVED BY HAND. THERE WAS SIGNIFICANT FIBROUS TISSUE OVER THE DISTAL FEMUR WITH CEMENT REMAINING ON PORTIONS OF THIS. THE TIBIAL BONE DEMONSTRATED MODERATE BONE LOSS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. UNABLE TO LOCATE SURGEON/PATIENT/SERIAL NUMBER IN EBI. NO SERIAL NUMBERS AVAILABLE. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS.

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

  MAUDE report 21103348 ↗
• InjuryDec 30, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21038149 ↗
• InjuryOct 9, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE (B)(6) CASE-2019-00005485 RK 2 STAGE REV1 CASE-2023-00007260 RK REV3 AS REPORTED BY THE LEGAL BRIEF A PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2009, AND CONTINUED TO HAVE PAIN AND INSTABILITY IN CONNECTION WITH HER OPTETRAK KNEE REPLACEMENT SYSTEM IT WAS DETERMINED THAT THE DEVICE HAD AGAIN LOOSENED AND FAILED AND WAS REQUIRED TO UNDERGO ANOTHER REVISION ON (B)(6) 2012, APPROXIMATELY 3 YEARS 8 MONTHS POST REVISION. AT THIS SECOND REVISION, ANOTHER INSERT WAS IMPLANTED IN PATIENT'S KNEE. 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. CONCOMITANT PRODUCTS: - STEM EXTENSION W/SLOT 120L X16 MM (CAT# 204-36-12 / SERIAL# (B)(6) - CC POSTERIOR FEM AUGMENT SZ 2, 5MM (CAT# 208-07-02 / SERIAL# (B)(6) - CC POSTERIOR FEM AUGMENT SZ 2, 5MM (CAT# 208-07-02 / SERIAL# (B)(6) - CC DISTAL FEM AUGMENT SZ 2, 5MM (CAT# 208-05-02 / SERIAL# (B)(6) - CC DISTAL FEM AUGMENT SZ 2, 5MM (CAT# 208-05-02 / SERIAL# (B)(6) - 3" TROCAR, MOD. HEX 2PK (CAT# 201-78-81 / SERIAL# (B)(6) - CC

  Patient problems: Joint Laxity; Pain

  MAUDE report 20407617 ↗
• InjuryJul 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 84 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAINFUL TKA PLACEMENT. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Joint effusion; Pain

  MAUDE report 19710069 ↗
• InjuryMar 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2009 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 14 YEARS AFTER INITIAL IMPLANT. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 18825532 ↗
• InjuryDec 18, 2023Naturally Worn; Naturally Worn

  AS REPORTED, ON 28-NOV-2023 THIS PATIENT WAS IMPLANTED WITH A 208-22-11CC TIBIAL INSERT SZ 2, 11MM, SERIAL NUMBER (B)(6) ON (B)(6) 2015. PATIENT REVISED ON (B)(6) 2023 DUE TO POLYETHYLENE WEAR WITH OSTEOLYSIS. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. THE INSERT WAS MANUFACTURED ON 2/13/2015. AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

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

  MAUDE report 18347108 ↗
• InjuryJul 27, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 8 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022. 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. REVISION OP REPORT ON (B)(6) 2022: DIAGNOSIS: OSTEOLYSIS, INSTABILITY, FEMORAL LOOSENING. SOFT TISSUE MASS LEFT KNEE. THERE WAS SIGNIFICANT EFFUSION AND SYNOVITIS. NO PURULENCE. THERE WAS DELAMINATION OF THE POLYETHYLENE BUT NOT EVIDENCE OF PROSTHESIS LOOSENING. THERE WAS SIGNIFICANT OSTEOLYSIS BEHIND THE FEMUR AND IN THE PROXIMAL TIBIA. A DRESSING WAS APPLIED. PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Joint Laxity; Joint effusion; Osteolysis; Synovitis

  MAUDE report 17404297 ↗
• 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 208-22-11-INSERTO TIBIAL CC 2,11MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 10/20/2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 10/20/2011 AND WAS 1.37 YEARS 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: Failure of Implant; Insufficient Information

  MAUDE report 16952737 ↗
• InjuryMay 11, 2023Adverse 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 77 Y/O MALE PATIENT HAD A RIGHT KNEE POLY EXCHANGE OF POSSIBLE RECALLED POLY. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS AND X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL WILL NOT ALLOW REP TO RETRIEVE ANY EXPLANTED PRODUCT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16916589 ↗
• InjuryApr 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT IS VERIFIED RIGHT KNEE DONE (B)(6) 2005. SHE HAD THE RIGHT KNEE REVISED ON (B)(6) 2023, APPROXIMATELY 17 YEARS AND 8 MONTHS AFTER THEIR INITIAL PROCEDURE. PERIPROSTHETIC OSTEOLYSIS OF INTERNAL PROSTHETIC KNEE JOINT. THERE WAS SIGNIFICANT EFFUSION AND SYNOVITIS. NO PURULENCE. THERE WAS DELAMINATION OF THE POLYETHYLENE BUT NO EVIDENCE OF PROSTHESIS LOOSENING. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. 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: Osteolysis

  MAUDE report 16791655 ↗
• InjuryJan 23, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL TEAM, IN 2006, PATIENT SOUGHT TREATMENT FOR KNEE PAIN. AT THE RECOMMENDATION OF THE ORTHOPEDIC SURGEON, SHE UNDERWENT KNEE REPLACEMENT SURGERY ON HER RIGHT KNEE WITH AN OPTETRAK KNEE REPLACEMENT SYSTEM, INCLUDING THE DEFECTIVE INSERT AND DEFECTIVE TIBIAL TRAY. IN 2008, LESS THAN TWO YEARS AFTER HER KNEE REPLACEMENT SURGERY, PATIENT DEVELOPED LOOSENING OF THE DEVICE AND PAIN IN HER RIGHT KNEE. ON (B)(6) 2008, PATIENT UNDERWENT A SURGICAL REVISION OF HER RIGHT KNEE DUE TO "FAILED RIGHT KNEE WITH A LOOSE TIBIAL COMPONENT". AT THE TIME OF SURGERY, IT WAS DISCOVERED THAT PATIENT RIGHT KNEE WAS ALSO INFECTED AND, THEREFORE, THE OPTETRAK KNEE REPLACEMENT SYSTEM AND ITS COMPONENTS WERE REMOVED WHILE PATIENT UNDERWENT TREATMENT FOR THE INFECTION. PATIENT CONTINUED TREATMENT FOR THE INFECTION UNTIL (B)(6) 2009, WHEN ANOTHER OPTETRAK KNEE REPLACEMENT SYSTEM WAS IMPLANTED IN HER RIGHT KNEE, ALONG WITH ANOTHER DEFECTIVE INSERT. AT THAT TIME, UNBEKNOWNST TO PATIENT, PATIENT CONTINUED TO HAVE PAIN AND INSTABILITY IN CONNECTION WITH HER OPTETRAK KNEE REPLACEMENT SYSTEM AND, IN (B)(6) 2012, IT WAS DETERMINED THAT THE DEVICE HAD AGAIN LOOSENED AND FAILED, AND THAT, THEREFORE

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 16225215 ↗
• InjuryOct 27, 2022Adverse 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 A TKA ON (B)(6) 2014. THE PATIENT WAS REVISED ON (B)(6) 2020 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15681086 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 5.29 YEARS SINCE INITIAL IMPLANT, THIS FEMALE PATIENT WITH BMI 18.7 UNDERWENT A (LEFT) SIDE TKA AND WAS IMPLANTED WITH AN EXACTECH UHMWPE INSERT, SERIAL # (B)(4). ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING.

  Patient problems: Failure of Implant

  MAUDE report 13422748 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2013, DUE TO INFECTION. INITIAL SURGERY DATE WAS (B)(6) 2012. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10775671 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-