Optetrak 200-04-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862039767), received between Nov 12, 2020 and Jun 23, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 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 22306746 ↗
• InjuryMay 2, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 111 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE THE PATIENT DEVELOPED INCREASING DISCOMFORT AND POLYETHYLENE WEAR WAS INDICATED BY X-RAY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE. INTRAOPERATIVELY, THE SURGEON OBSERVED SIGNIFICANT METAL STAINING ON ALL SURFACES OF THE SYNOVIUM IN ADDITION TO DAMAGE OF THE POLY COMPONENT. IT WAS NOTED THERE WAS NO BONE LOSS. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint effusion; Metal Related Pathology; Synovitis

  MAUDE report 21950639 ↗
• InjuryMar 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 48 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, CYST(S), OSTEOLYSIS, AND PAIN. 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: Ambulation or Postural Difficulties; Cyst(s); Osteolysis; Pain

  MAUDE report 21503421 ↗
• InjuryFeb 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 108 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, CYST AND OSSIFICATION. INITIAL SURGERY AND 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: Cyst(s); Extraskeletal ossification

  MAUDE report 21470929 ↗
• InjuryJan 30, 2025Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect; Mechanical Problem; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Lack of Effect

  IT WAS REPORTED THAT APPROXIMATELY 140 MONTHS AFTER A TOTAL REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, OSTEOLYSIS, SYNOVITIS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21277790 ↗
• InjuryJan 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 180 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s); Failure of Implant; Osteolysis

  MAUDE report 21276069 ↗
• InjuryJan 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, A LOOSE TIBIAL COMPONENT, POLYETHYLENE WEAR, AND BONE LYSIS. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 21207702 ↗
• InjuryFeb 13, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA A LEGAL NOTIFICATION, THAT PATIENT, UNDERWENT INITIAL RIGHT KNEE REPLACEMENT SURGERY ON (B)(6) 2010 AND WAS IMPLANTED WITH A OPTETRAK DEVICE. SPECIFICALLY, PLAINTIFF WAS IMPLANTED WITH A OPTETRAK POSTERIOR STABILIZED TIBIAL INSERT, ALONG WITH AN OPTETRAK STEM, OPTETRAK PATELLA, OPTETRAK SCREWS, A OPTETRAK TIBIAL TRAY, AND A OPTETRAK POSTERIOR STABILIZED FEMORAL COMPONENT. FOLLOWING THE SURGERY, PLAINTIFF BEGAN EXPERIENCING WORSENING SYMPTOMS, PAIN, INSTABILITY, EFFUSION, AND ANTALGIC GATE. PLAINTIFF UNDERWENT A RIGHT KNEE REVISION SURGERY ON (B)(6) 2020, APPROXIMATELY 10 YEARS 4 MONTHS POST INITIAL PROCEDURE. PLAINTIFF CONTINUES TO EXPERIENCE PAIN AND DISCOMFORT ON A DAILY BASIS IN HIS RIGHT KNEE WHICH LIMITS HIS DAILY ACTIVITIES AND QUALITY OF LIFE. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. NO FURTHER INFORMATION.

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

  MAUDE report 16366479 ↗
• InjuryNov 12, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RIGHT KNEE REVISION SURGERY ON (B)(6) 2015, DUE TO ASEPTIC LOOSENING. INITIAL SURGERY DATE WAS (B)(6) 2009. NO ADDITIONAL INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 10833476 ↗

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