Optetrak 200-73-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862041258), received between Oct 18, 2019 and May 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 73 YO FEMALE PATIENT, INITIAL LEFT KNEE IMPLANTED IN (B)(6) 2014, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2025, APPROXIMATELY 10 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON AS PART OF THE RECALL. THEY WERE PAIN FREE BUT HAD SIGNIFICANT WEAR ON BOTH CONDYLES OF THE POLYETHYLENE. THE PATELLA WAS ALSO REPLACED, ALTHOUGH NO WEAR WAS OBSERVED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THEY WERE DISPOSED OF BY THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS. RIGHT KNEE REVISION MENTIONED ON REPORT SUBMITTED UNDER MDR#1038671-2023-01420.

  Patient problems: Insufficient Information

  MAUDE report 21970831 ↗
• InjuryAug 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT AN 82 YO MALE PATIENT, WHO HAD BILATERAL KNEE REPLACEMENTS AND WAS IMPLANTED WITH RECALLED POLY, PRESENTED TO THE SURGEON¿S OFFICE WITH COMPLAINTS OF PAIN, SWELLING, INSTABILITY AND DISSATISFACTION WITH BOTH THEIR TKA¿S. THE LEFT KNEE HURT MORE THAN THE RIGHT AT THIS TIME HOWEVER, THE SURGEON NOTED ON THE X-RAY THAT THE RIGHT KNEE LOOKED WORSE WITH POLY WEAR AND POSSIBLE LOOSENING OF THE IMPLANTS. THE INITIAL RIGHT KNEE REPLACEMENT OCCURRED ON (B)(6) 2012. NO REVISION OF THE RIGHT KNEE HAS OCCURRED CURRENTLY. X-RAY PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17631642 ↗
• 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 200-73-09-INSERTO TIBIAL SLOPE++ CR 3-9 MM, SERIAL NUMBER 3784459 ON 3/4/2015. THE INSERT WAS MANUFACTURED ON 11/21/2014 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 11/21/2014 AND WAS 0.28199863107460643 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 16955573 ↗
• InjuryMay 17, 2023Naturally Worn; Naturally Worn

  DURING THE WEEK OF (B)(6) 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 200-73-09-INSERTO TIBIAL SLOPE++ CR 3-9 MM, SERIAL NUMBER (B)(6) ON (B)(6) 2013. THE INSERT WAS MANUFACTURED ON 09-MAR-2011 AND WAS PACKAGED IN A VACUUM BAG WITH NO EVOH. THE INSERT WAS MANUFACTURED ON 27-MAY-2013 AND WAS 2.22 YEARS SHELF AGE AT THE TIME OF IMPLANT. ON (B)(6) 2017, APPROXIMATELY 4 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 16950614 ↗
• InjuryDec 8, 2022Fracture; Unstable; Naturally Worn; Fracture; Unstable; Naturally Worn

  AS REPORTED BY THE LEGAL BRIEF, IN (B)(6) 2012, PATIENT (55-YEAR-OLD AT THE TIME) UNDERWENT THIS TKA SURGERY IN HIS RIGHT KNEES WHERE THE SURGEON IMPLANTED DEFENDANTS¿ OPTETRAK, CR, POROUS FEMORAL COMPONENT, OPTETRAK, FINNED, CEMENTED TIBIAL TRAY, OPTETRAK, CR TIBIAL INSERT, AND PATELLA SINGLE PEG. THE ALLEGATIONS IN THIS COMPLAINT RELATE TO THE EARLY FAILURE OF THE DEFECTIVE DEVICE, ITS TIBIAL TRAY AND ITS POLYETHYLENE COMPONENT. THE SUBSEQUENT REVISION SURGEON NOTED THAT THERE WAS CATASTROPHIC FAILURE WITH FRACTURE OF THE POLYETHYLENE INSERT AS WELL AS A TIBIAL INSERT COMPONENT WITH METAL-ON-METAL ARTICULATION BILATERALLY. THE COMPONENTS OF THE DEVICE WERE DEFECTIVE, UNREASONABLY DANGEROUS AND FAILED RESULTING IN LOOSENING, MALPOSITIONING OF THE IMPLANT, AND RUBBING/WEAR OF THE COMPONENTS CAUSING METALLOSIS, INSTABILITY, LIMITED MOBILITY, SWELLING AND PAIN. THE EXTENT OF THE COMPONENTS¿ FAILURE WAS DISCOVERED UPON PATIENT¿S RIGHT KNEE REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15943316 ↗
• InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  TIBIAL TRAY AND INSERT REVISED TO STEMMED TIBIAL TRAY AND CRC INSERT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL KEPT IT.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 9208687 ↗