Optetrak 202-04-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862046789), received between Mar 19, 2026 and Mar 19, 2026 — classified as 1 injury.

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

• InjuryMar 19, 2026Naturally Worn

  AS REPORTED, IN 2021 A SALES REP INFORMED US THAT THERE IS A PLAN THAT THE RECALL INSERT WILL BE RETRIEVED AT REVISION SURGERY AROUND WEEK AFTER NEXT DUE TO POSTERIOR WEAR OF THE INSERT. IN (B)(6) 2026 THE REVISION OCCURRED. THE PATIENT WHO HAD A RIGHT TKA USING A CR SLOPE+ TIBIAL INSERT COMPLAINED OF KNEE SWELLING AND PAIN. THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT. THE REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WERE OBSERVED IN THE RETRIEVED TIBIAL INSERT AS WELL AS TIBIAL TRAY. THE SURGEON DECIDED THAT THE INSERT AND TIBIAL TRAY ONLY WERE REPLACED WITH A NEW CRC SIZE 3 13 MM NEUTRAL INSERT AND TIBIAL TRAY 3F/2T. THERE WAS DEVICE BREAKAGE, WHICH WAS RETRIEVED FROM THE WOUND SITE. POLYETHYLENE PARTICLES WERE REMOVED BY THE SURGEON APPROPRIATELY. THERE WERE NO SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24643082 ↗