Optetrak 200-22-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862040190), received between Mar 23, 2023 and Mar 12, 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.

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

• InjuryMar 12, 2026Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS AND 11 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED WEAR OF THE TIBIAL INSERT AND THE PATIENT WAS REVISED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT. THE SURGEON DECIDED THERE WAS NO PROBLEM WITH THE LOCKING MECHANISM OF THE TIBIAL TRAY, AND ONLY THE INSERT WAS REPLACED WITH A NEW TRULIANT CR SIZE 2, 13MM NEUTRAL INSERT. POLYETHYLENE PARTICLES WERE REMOVED BY THE SURGEON APPROPRIATELY. 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 24582298 ↗
• InjuryJun 18, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 86 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, REVISION SURGERY, WEAKNESS OF LEFT LOWER EXTREMITY, DIFFICULTY WALKING, DIFFICULTY WITH PROLONGED STANDING, IMPAIRED STAIR/CURB NEGOTIATION, IMPAIRED TRANSFER/FUNCTIONAL MOBILITY, NEW AND WORSENING PAIN IN KNEE, INABILITY TO BEAR WEIGHT ON JOINT, AND KNEE INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 19563549 ↗
• InjuryApr 10, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 12 YEARS AND 3 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO DEVICE INFORMATION PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 19080018 ↗
• InjuryOct 25, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2014. APPROXIMATELY 8 YEARS AND 4 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. 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 MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044 (NGG) (MMH), AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18001864 ↗
• InjurySep 15, 2023Fracture; Naturally Worn; Insufficient Device Problem Information; Fracture; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, APPROXIMATELY 10 YEARS POST OP INITIAL TKA, THIS 63 Y/O MALE PATIENT WAS REVISED DUE TO THE RECALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN X-RAYS OR IMAGES. NOT RETURNING - HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17756921 ↗
• InjuryMay 26, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2014. APPROXIMATELY 2 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2016 DUE TO PAIN, DIFFICULTY WITH WALKING AND ACTIVITIES. 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; Failure of Implant; Implant Pain; Joint Laxity; Scar Tissue

  MAUDE report 17009021 ↗
• 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 200-22-09-INSERTO TIBIAL CR 2, 9MM, SERIAL NUMBER (B)(6), ON (B)(6) 2016. THE INSERT WAS MANUFACTURED ON (B)(6) 2015 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON (B)(6) 2015 AND WAS SEVEN MONTHS SHELF AGE AT THE TIME OF IMPLANT. APPROXIMATELY SEVEN YEARS POST IMPLANTATION, THE PATIENT IS PENDING REVISION FOR WEAR OF THE POLYETHYLENE. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Corneal Stromal Edema; Insufficient Information

  MAUDE report 16971067 ↗
• InjuryMar 23, 2023Unstable; Material Deformation; Naturally Worn; Unstable; Material Deformation; Naturally Worn

  IT WAS REPORTED FROM THE LEGAL DEPARTMENT THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION OF THE LEFT KNEE DEVICE SECONDARY TO ONGOING OSTEOLYSIS DUE TO POLYETHYLENE LINER WEAR RESULTING IN ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AND BONE GRAFTING OF THE FEMUR. IT IS ALSO STATED THAT DESPITE UNDERGOING THE REVISION SURGERY, THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. 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; Emotional Changes; Joint Laxity; Osteolysis; Pain

  MAUDE report 16606643 ↗

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