Triathlon 5565-S-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026740), received between May 27, 2021 and May 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryMay 27, 2021Loss of Osseointegration; Loss of Osseointegration

  IN PERFORMING FOLLOW-UP, REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2013 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: LOOSE RIGHT REVISION KNEE ARTHROPLASTY WITH MALTRACKING OF PATELLA. OP REPORT NOTES: "IN LESS THAN 1 YEAR SHE DEVELOPED INCREASING PAIN AND DISCOMFORT. STUDIES ARE SUSPICIOUS FOR POSSIBLE LOOSENING OF FEMORAL COMPONENT. THERE WAS ONLY SOME DISTAL CEMENT AROUND THE FEMORAL COMPONENT. THE STEM APPEARED TO BE REACTIVE LINE AROUND IT SUGGESTING LOOSENING OF FEMORAL COMPONENT.THE PATELLA WAS ALSO TILTING AND MALTRACKING. FEMORAL COMPONENT CAME OUT VERY EASILY WITH NO FIXATION AT ALL. THE CEMENT WAS BONDED TO THE IMPLANT WITH AUGMENTS. THE STEM CAME OUT AND THERE WAS A FIBROUS MEMBRANE AROUND THE STEM COMPLETELY. THERE WAS NO CEMENT ON THE STEM AT ALL CONSISTENT WITH FEMORAL COMPONENT LOOSENING...WE HAD TO REMOVE THE PATELLAR COMPONENT TO POSITION IT MORE CENTRALLY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11899110 ↗