Optetrak 210-01-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862057419), received between Feb 18, 2025 and Nov 17, 2025 — 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 16, 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 17, 2025Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth; Mechanical Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING, STIFFNESS, LOSS OF MOTION, WEAKNESS AND DIFFICULTY AMBULATING. AS A RESULT, THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 13 YEARS AND 7 MONTHS AFTER INITIAL IMPLANTATION. PROVIDED OPERATIVE NOTES REPORT TIBIAL LOOSENING AND WEAR OF THE TIBIAL INSERT. IT WAS LATER REPORTED THAT THE FEMORAL COMPONENT WAS FOUND TO BE DEBONDED. THE PATIENT WAS LAST REPORTED TO BE STABLE. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 23575362 ↗
• InjuryFeb 18, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 87 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PROSTHESIS WEAR, EFFUSION AND INSTABILITY. A REVISION OPERATIVE REPORT WAS PROVIDED. POST OPERATIVE DIAGNOSIS NOTED INSTABILITY AND FEMORAL COMPONENT LOOSENING. INTRAOPERATIVELY THE SURGEON OBSERVED SIGNIFICANT EFFUSION AND SYNOVITIS AND DELAMINATION OF THE POLYETHYLENE COMPONENT. IT WAS NOTED THERE WAS NO EVIDENCE OF THE POLYETHYLENE TIBIAL COMPONENT LOOSENING. THE SURGEON OBSERVED THE TIBIA WAS WELL FIXED BUT THERE WAS DEBONDING OF THE FEMORAL COMPONENT AT THE IMPLANT CEMENT INTERFACE. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 21401871 ↗

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-