Optetrak 200-74-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862041296), received between May 13, 2020 and Jun 23, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 10 YEARS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PREMATURE POLYETHYLENE WEAR WITH MASSIVE FEMORAL AND TIBIAL OSTEOLYSIS. THE PATIENT WAS REVISED TO A COMPETITOR DEVICE WITH METAPHYSEAL CONES AT THE FEMORAL AND TIBIAL LEVELS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 22306713 ↗
• InjuryJul 22, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 122 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, ADVANCED METALLOSIS AND OSTEOLYSIS OF THE FEMUR AND TIBIA. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Metal Related Pathology; Osteolysis

  MAUDE report 19799891 ↗
• InjuryJul 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2010. THEY UNDERWENT RIGHT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 9 YEARS 8 MONTHS POST PRIMARY PROCEDURE. 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: Insufficient Information

  MAUDE report 17361472 ↗
• InjuryDec 6, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED BY LEGAL BRIEF, IN (B)(6) OF 2012, PATIENT (55-YEAR-OLD AT THE TIME) UNDERWENT THIS TKA SURGERY IN HIS LEFT KNEE 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 LEFT KNEE REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15928289 ↗
• InjuryMay 13, 2020Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 9.5 YRS POSTOP TKA, A FAIRLY ACTIVE (B)(6) Y/O MALE PATIENT COMPLAINED OF PAIN, INSTABILITY, AND LOOSENING. ALSO ¿SLOW SWELLING¿ AND DECREASED RANGE OF MOTION STARTED 4-5 YEARS AGO¿. FLUID WAS DRAINED TO TEST FOR INFECTION AND WAS NEGATIVE. PATIENT WAS REVISED TO A HINGED KNEE. PT REPORTED SURGEON NOTED CEMENT COMING APART, LOOSE PLASTIC, AND OSTEOLYSIS AT SITE, AL DEVICES WERE REMOVED AND REPLACED. PT COMPLAINED THAT THIS RECOVERY WAS MUCH MORE PAINFUL THAT THE INITIAL IMPLANT RECOVERY.

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

  MAUDE report 10051680 ↗