INSTRUMENT 6541-3-339Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327195866), received between Oct 4, 2018 and Oct 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 18, 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.

• InjuryOct 4, 2018Use of Device Problem; Use of Device Problem

  PRIMARY TKA WAS PERFORMED ON (B)(6) 2018. PATIENT COMPLAINED OF KNEE PAIN AND HAD DIFFICULTY IN THERAPY. APPROXIMATELY 3 WEEKS LATER THE PATIENT WAS IN THE CLINIC TO SEE DR FOR A FOLLOW UP ON POST OP ISSUES. X-RAYS REVEAL THERE WAS A SYMMETRIC PATELLA CAPTURE IMPLANTED ON THE PATELLA IMPLANT IN THE PATIENT. THE PATIENT WAS THEN SCHEDULED FOR A REVISION TKA. THE REVISION WAS SUCCESSFUL IN REMOVING THE SYMMETRIC PATELLA CAPTURE. UPDATE 10/SEPTEMBER/2018: AS CITED IN "ADVERSE CONSEQUENCES DETAILS": RANGE OF MOTION WAS NOT ACHIEVED. REP ADVISED THAT NONE OF THE REPORTED IMPLANTS WERE REVISED. ONLY THE PATELLA CAPTURE (NOT THE PATELLA) WAS REMOVED. PRE-REVISION X-RAYS, PRIMARY OPERATIVE REPORT, AND USAGE SHEET ARE PROVIDED.

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 7934143 ↗