Optetrak 210-01-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862057396), received between Mar 23, 2020 and Nov 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K954208); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2024Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 129 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, FAILURE OF LEFT KNEE TOTAL KNEE ARTHROPLASTY PROSTHESIS WITH LOOSE COMPONENTS; CORTICAL FRACTURE OF LEFT FEMUR; SEVERE OSTEOLYSIS, LOSS OF RANGE OF MOTION; CHRONIC PAIN; INJURIES TO TISSUE AND CONE OF THE LEFT KNEE; SUBCHONDRAL CYST; JOINT EFFUSION; METALLOSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Bone Fracture(s); Cyst(s); Failure of Implant; Implant Pain; Joint effusion; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 20688801 ↗
• InjuryMar 23, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 9 YEARS POSTOP TKA THIS (B)(6) Y/O FEMALE PATIENT, WEIGHT (B)(6)LBS, PRESENTED RECENTLY WITH KNEE PAIN AND IT WAS DISCOVERED THAT THE SPINE STIFFENING SCREW HAD MIGRATED SUPERIOR. PRE-OP PLANNING WAS THE INSERT WOULD BE REPLACED AND IF SCREW WAS DAMAGED THE ENTIRE TIBIAL COMPONENT WOULD BE REPLACED; HOWEVER, PRIOR TO THE CASE, IT WAS DETERMINED THAT THE TIBIA WILL REMAIN DUE TO THE PATIENT IS ELDERLY AND NOT ACTIVE OR OBESE. AS INSERT WAS BEING REMOVED IT WAS DISCOVERED THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON DID NOT WANT THE PATIENT TO GO THRU A REVISION AS THE BONE WAS GOOD AND THE SURGEON WANTED TO CLEAN AND REMOVE SOME OLD CEMENT AND INSERT A NEW SIZE 2 NMC FEMUR, WHICH WAS CEMENTED IN PLACE. WHILE REPLACING THE INSERT, IT WAS NOTED THAT THE SCREW WOULD NOT ENGAGE THE STEM. THE SURGEON DECIDED TO IMPLANT A15MM INSERT W/O THE SPINE STIFFENING SCREW WITH NO HARM TO PATIENT. DUE TO THE AGE, HEALTH AND ACTIVITY LEVEL OF THE PATIENT THE SURGEON DECIDED NOT TO STEM A FEMUR BUT TO REPLACE IT WITH A NEW NMC FEMUR AND REPLACE THE INSERT W/O THE SPINE SCREW. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE

  Patient problems: Failure of Implant

  MAUDE report 9868261 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-