Optetrak 200-21-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862040152), received between Mar 27, 2024 and Jun 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Naturally Worn

  REPORT #3 OF 3 FOR THIS EVENT. AS REPORTED BY LEGAL DOCUMENTATION, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY TEN (10) YEARS LATER, THE PATIENT PRESENTED TO SURGEON COMPLAINING OF PAIN UNRELATED TO INJURY/WORK INJURY. PATIENT REPORTS 8 OUT OF 10 ON PAIN SCALE IN LEFT AND RIGHT KNEES. ONGOING INTERMITTENT ACHING. GRADUALLY WORSENING. AGGRAVATED BY: BENDING, STRETCHING, STRAIGHTENING, EXERCISE, KNEELING, SQUATTING, STANDING, WALKING, STAIRS. PATIENT REPORTED FALLING ON BOTH KNEES WHILE WALKING THE DOG. RADIOGRAPHS, PER THE SURGEON APPEARS TO DEMONSTRATE LUCENCY ABOUT THE TIBIAL PLATEAU COMPONENT OF THE PROSTHESIS AND FEMORAL COMPONENT OF THE PROSTHESIS ON THE LEFT THAT MAY REPRESENT LOOSENING. MEDICAL RECORDS AND CLINICAL HISTORY WERE PROVIDED. IT IS UNKNOWN IF THE PATIENT UNDERWENT REVISION OF THE LEFT KNEE OR IF A LEFT KNEE REVISION IS PLANNED OR SCHEDULED. THE PATIENT WAS REFERRED TO AN ORTHOPAEDIC SURGEON FOR CONSULTATION OF POSSIBLE REVISION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Pain

  MAUDE report 25450349 ↗
• InjuryMar 27, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2011 AND THEN APPROXIMATELY 12 YEARS, 11 MONTHS LATER ON (B)(6) 2024 THE PATIENT HAD A SURGICAL REVISION. REVISION OPERATIVE REPORT 8 JAN 2024-POSTOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING OF RIGHT TOTAL KNEE. PATIENT REVISED TO COMPETITOR'S DEVICES. PATIENT WITH RADIOGRAPHIC EVIDENCE OF ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS WITH AREAS OF OSTEOLYSIS IN FEMUR AND TIBIA. NEGATIVE FOR INFECTION. THERE IS EVIDENCE OF CATASTROPHIC POLYETHYLENE WEAR WITH VISUAL DETERIORATION OF THE POLYETHYLENE WITH MULTIPLE POLYETHYLENE FRAGMENTS THROUGHOUT THE KNEE. PATELLA POLYETHYLENE COMPONENT WAS UNDERMINED WITH AREAS OF OSTEOLYSIS. THE PATIENT WAS AWAKENED AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Implant Pain; Osteolysis; Pain

  MAUDE report 18985313 ↗

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