Optetrak 200-04-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862039729), received between Nov 13, 2023 and Aug 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 16, 2026.

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.

• InjuryAug 18, 2026Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  Report #2 of 2 for this event.It was reported via legal notification this patient, underwent an initial left total knee arthroplasty. Subsequently, then (10) years, three (3) months later, the patient experienced pain, swelling, instability, and bone loss of the left knee. As a result, the patient underwent a revision surgery. An operative report was provided. Post operative diagnosis noted mechanical loosening of internal left knee prosthetic joint and polyethylene wear of left knee joint prosthesis. Intraoperatively, the tibial component was noted to be loose. The patient was awoken and taken to the recovery room in stable condition.

  Patient problems: Ambulation or Postural Difficulties; Erosion; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 50301361 ↗
• InjuryJan 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6) 2013. THEY HAD RIGHT KNEE REVISION ON (B)(6) 2023, APPROXIMATELY 9 YEARS 6 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6) 2023 V SIMMS, RN/ REVISION OPERATIVE REPORT OF (B)(6) 2023- FAILED RIGHT KNEE REPLACEMENT. THE SPACER WAS COMPLETELY WORN OUT MEDIALLY AND SOMEWHAT LATERALLY, POSTERIORLY. AFTER THE FEMUR WAS TAKEN OUT, THE TIBIA POPPED OUT ON ITS OWN. ALL DEBRIS WAS REMOVED. THE PATELLA WAS REMOVED, IT WAS COMPLETELY WORN. HOSPITAL CARE: ADMITTED (B)(6) 2023; DISCHARGED (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS.

  Patient problems: Failure of Implant

  MAUDE report 21246279 ↗
• InjuryDec 31, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 120 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, PAIN, JOINT LAXITY, OSTEOLYSIS, SWELLING AND EDEMA.. 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: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 21047189 ↗
• InjuryNov 20, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 9 YEARS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA) USING CR SLOPE WITH TIBIAL INSERT, THE PATIENT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF ALL KNEE DEVICE WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. ALSO, DAMAGE WAS OBSERVED IN POSTERIOR OF TIBIAL TRAY DUE TO CONTACTING TO THE FEMORAL COMPONENT. THE SURGEON DECIDED TO REPLACE ALL COMPONENTS WITH A COMPETITOR PROSTHESIS. THE TIBIAL TRAY WAS DAMAGED AND FOUND METAL POWDER. THE SURGEON RETRIEVED AND CLEANED IT APPROPRIATELY DURING THE SURGERY. THE PATIENT'S BONE QUALITY WAS NORMAL AND THE PATIENT HAD HIGH ACTIVITY LEVEL. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT WORN A KNEE BRACE FOLLOWING SURGERY. THE EVENT DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint effusion; Pain

  MAUDE report 20738272 ↗
• InjuryNov 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE SURGEON STATED THE REASON FOR PATIENT'S KNEE REVISION WAS THE DE-BONDING OF THE TIBIAL TRAY. SURGEON REMOVED AN OPTETRAK TIBIAL TRAY AND INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION BECAUSE OF BIOLOGICAL HAZARD AND THE HOSPITAL TREATED IT AS SUCH.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18122262 ↗

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