Optetrak 200-06-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862039903), received between Feb 18, 2025 and Sep 24, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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.

• InjurySep 24, 2026Naturally Worn

  It was reported that the patient underwent a knee replacement utilizing an Optetrak CR Slope++ tibial insert. Subsequently, the patient experienced knee pain and swelling. The surgeon diagnosed wear of the tibial insert, and a revision procedure was performed. During the revision, damage and wear were observed on the retrieved tibial insert and tibial tray. As a result, the tibial insert, tibial tray, and femoral component were explanted and replaced with an Activit-E PSC Size 1, 15 mm insert, a Size 1F/1T tibial tray, and a Logic Femoral Component Size 1 Right. Additional implants utilized during the procedure included a 14 mm × 80 mm stem extension, two Size 1T 5 mm tibial augments, a Size 1 5 mm posterior femoral augment, a Size 1 10 mm femoral augment, and a Size 1 5 mm distal femoral augment. The patient outcome was not further reported.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 50881081 ↗
• InjuryFeb 18, 2025Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION A 59 Y/O PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2011. APPROXIMATELY 6 YEARS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2017 DUE TO SEVERE ARTICULAR SURFACE WEAR.

  Patient problems: Failure of Implant; Osteolysis; Scar Tissue; Synovitis

  MAUDE report 21401460 ↗