Optetrak 200-21-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862040145), received between Dec 8, 2020 and Sep 3, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 156 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 20126542 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT UNDERWENT TESTING AND RECEIVED A RIGHT KNEE REPLACEMENT IN 2011 AND 2012. EARLY ON, THE PATIENT EXPERIENCED INITIAL AND CONTINUING PAIN AND PROBLEMS WITH HER RIGHT KNEE AFTER THE SURGERY, REQUIRING REPEATED PROCEDURES TO DRAIN FLUID FROM HER RIGHT KNEE, WITH BIOPSIES OF THE FLUID, X¿RAYS, AND CT SCANS TO TRY TO DETERMINE THE SOURCE OF THE PROBLEMS THAT SHE WAS EXPERIENCING. IN 2013 TO 2014, WITH THE ORIGINAL TREATING PHYSICIAN NOW RETIRED, THE PATIENT WAS REFERRED TO ANOTHER SURGEON. THE SURGEON CONTINUED TO INVESTIGATE AND TREAT THE PROBLEMS WITH THE PATIENT¿S KNEE, RESULTING IN A SURGICAL REVISION TO THE ORIGINAL KNEE REPLACEMENT, WHICH REQUIRED REPLACING THE ORIGINAL DEVICE WITH AN EXACTECH KNEE REPLACEMENT DEVICE. EXPLANATION DATE/OCCURRENCE DATE OF THE FIRST REVISION SURGERY IS CURRENTLY UNKNOWN.

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 17859707 ↗
• InjuryNov 28, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED, SURGEON WAS STRUGGLING TO IMPLANT OUR POLY. POLY ENTIRE MEDIAL ARTICULATION SURFACE WAS DELAMINATED AND POSTERIOR PORTION WAS MISSING. FEMUR, THE COBALT CHROME FINISH WAS SCRATCHED DUE TO ARTICULATION WITH THE METAL OF THE TIBIA. TIBIA, THE POSTEROMEDIAL PORTION WAS ABSENT, LIKELY DUE TO DISLODGEMENT FROM THE POSTERIOR FEMUR. SURGEON DECIDED TO DO A FULL TWO COMPONENT REVISION WITH COMPETITOR'S DEVICE. THERE WERE NO IMAGES CAPTURED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

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

  MAUDE report 15874908 ↗
• InjuryDec 8, 2020Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS POSTOP A LEFT TKA ON THIS MALE PATIENT, A REVISION WAS COMPLETED. DURING THE PROCEDURE, THE SURGEON REPORTS THAT THERE WAS TISSUE NECROSIS. THE DEVICES WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Failure of Implant

  MAUDE report 10972466 ↗

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