Optetrak 204-01-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862047557), received between Feb 13, 2020 and Feb 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O (BMI=30), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2009. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2014, APPROXIMATELY 57 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO IMPLANT FRACTURE, INFECTION, OTHER INDICATION FOR REVISION, AND WEAR OF POLYETHYLENE COMPONENT. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. INFECTION IS A CLINICALLY WELL-KNOWN POTENTIAL COMPLICATION OF ANY SURGICAL PROCEDURE INCLUDING KNEE ARTHROPLASTY. IF INFECTION OCCURS AFTER KNEE REPLACEMENT, WHETHER RELATED TO THE PROCEDURE OR OTHERWISE, THE FOREIGN METAL AND PLASTIC IMPLANTS CAN SERVE AS A SURFACE FOR THE BACTERIA TO LATCH ONTO, INACCESSIBLE TO ANTIBIOTICS. EVEN IF THE IMPLANTS REMAIN WELL FIXED, THE PAIN, SWELLING, AND DRAINAGE FROM THE INFECTION MAKE THE REVISION SURGE

  Patient problems: Failure of Implant

  MAUDE report 9709875 ↗