Optetrak 200-72-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862041210), received between Dec 13, 2022 and Apr 8, 2026 — classified as 8 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.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 7.5 YEARS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN AND WAS DIAGNOSED WITH WEAR OF THE TIBIAL INSERT. THE PATIENT WAS REVISED AND DAMAGE AND WEAR WERE OBSERVED ON THE RETRIEVED TIBIAL INSERT, AS WELL AS THE TIBIAL TRAY. THE SURGEON DECIDED THAT ONLY THE INSERT AND TIBIAL TRAY NEEDED TO BE REPLACED WITH A TRULIANT CRC SIZE 2 15 MM INSERT AND TIBIAL TRAY 2F/1T. A STEM EXTENTION 14MM×40MM, 1/2 TIBIAL AUGMENT SIZE 1T-5MM (X2), 1/2 TIBIAL AUGMENT RM/LL SIZE 1T-10MM AND 1/2 TIBIAL AUGMENT RL/LM SIZE 1T-10MM WERE ALSO USED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24815251 ↗
• InjuryJan 7, 2025Fracture; Structural Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Structural Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA. PATIENT ID: (B)(6) + RIGHT KNEE. CASE (B)(4) IS ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT AN ARTHROSCOPY PROCEDURE DUE TO SYNOVITIS AND LOOSENING. PATIENT BEGAN EXPERIENCING PAIN, POPPING, CLICKING AND CATCHING OF THE RIGHT KNEE AFTER A FALL APPROXIMATELY 7 MONTHS PRIOR. ARTHROSCOPIC SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS INDICATED SYNOVITIS, TIBIAL COMPONENT LOOSENING, METALLOSIS, AND FRACTURED TIBIAL POLYETHYLENE WITH LOOSE FRAGMENTS. SURGEON PERFORMED A THREE COMPARTMENT SYNOVECTOMY AND LOOSE BODY REMOVAL FROM WITHIN THE NOTCH. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Metal Related Pathology; Pain; Peeling; Synovitis

  MAUDE report 21092507 ↗
• InjurySep 3, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2016, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 8 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WHO HAD A TOTAL KNEE ARTHROPLASTY USING CR SLOPE ++ TIBIAL INSERT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED THE WEAR AND DAMAGE OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. NO PARTS OR PIECES OF THE TIBIAL TRAY FELL INTO THE WOUND SITE. THE SURGEON DECIDED THAT NO PROBLEM OF LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND, AND THE INSERT ONLY WAS REPLACED TO A NEW TRULIANT CR INSERT NEUTRAL SIZE 2 12MM. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICE IS NOT RETURNING: A RETRIEVED INSERT WOULD BE USED FOR CLARIFICATION TO A PATIENT. DEVICE IMAGES OF THE EXPLANTED DEVICE WAS PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 20131558 ↗
• InjurySep 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SCAR TISSUE AND SYNOVITIS. OP REPORT NOTED POLY HAD SEVERE WEAR PATTERN AND PULSED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 20125373 ↗
• InjuryMay 18, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF APRIL (B)(6), 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 200-72-09-INSERTO TIBIAL SLOPE++ CR 2-9 MM, SERIAL NUMBER (B)(6) ON (B)(6) 2015. THE INSERT WAS MANUFACTURED ON 4/17/2013 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 4/17/2013 AND WAS 2.01 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2022 APPROXIMATELY 7.0 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 16958346 ↗
• InjuryApr 13, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED PER LEGAL TEAM, THE 77 Y/O FEMALE PATIENT THAT HAD AN ORIGINAL KNEE REPLACEMENT ROUGHLY 10 YEARS AGO. THE PATIENT IS NEEDING A FULL KNEE REVISION DUE TO LYSIS ON THE BONE AND POLY WEAR.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 16736632 ↗
• InjuryMar 27, 2023Material Integrity Problem; Naturally Worn; Material Integrity Problem; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED BY THE LEGAL DEPARTMENT ON (B)(6) 2023 : ON (B)(6) 2023 , THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT REVISION OF THE EXACTECH KNEE DEVICE SECONDARY TO POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS, LINER BREAKAGE, AND ASEPTIC LOOSENING. 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.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Joint effusion; Osteolysis; Pain; Scar Tissue

  MAUDE report 16617385 ↗
• InjuryDec 13, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2015. THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN AND THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT. THE PATIENT WAS REVISED ON (B)(6) 2022. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT, AS WELL AS METALLOSIS. THE SURGEON REMOVED PARTS AND PIECES OF POLYETHYLENE PARTICLES AND PROLIFERATIVE TISSUES WERE RESECTED BY THE SURGEON APPROPRIATELY.

  Patient problems: Failure of Implant; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 15969400 ↗