Triathlon 5551-L-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327049855), received between Aug 24, 2017 and Sep 7, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2020Off-Label Use; Osseointegration Problem; Insufficient Device Problem Information; Off-Label Use; Osseointegration Problem; Insufficient Device Problem Information

  GAVE SURGEON THE WRONG IMPLANT. CEMENTED PATELLA WAS PUT IN, IN AN UNCEMENTED NATURE. A SECOND SURGERY IS REQUIRED TO REMOVE PATELLA AND PLACE A CORRECT PATELLA.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10499243 ↗
• MalfunctionDec 27, 2017Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT IN PERFORMING A PRIMARY IMPLANT FOR PATIENT'S KNEE (SIDE UNKNOWN), A HAIR WAS FOUND ON THE UNDERSIDE OF THE PATELLA IMPLANT UPON REMOVING IT FROM THE INNER PACKAGE. SURGEON ELECTED NOT TO USE THE IMPLANT DUE TO STERILITY CONCERNS. ANOTHER IMPLANT WAS IMMEDIATELY AVAILABLE AND NO SURGICAL DELAY WAS CAUSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7147568 ↗
• InjuryAug 24, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT UNDERWENT A REVISION OF HIS RIGHT MEDIAL UNI-COMPARTMENT TO A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016. HE FURTHER ALLEGES THAT HE CONTINUES TO HAVE PAIN AND LOOSENING OF HIS KNEE COMPONENT. HE SCHEDULED FOR A SECOND REVISION. SALES REP REPORTED A PRIMARY REVISION OF A RIGHT TOTAL KNEE DUE TO LOOSE TIBIAL TRAY. NO TRAUMA OR DELAY.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 6817733 ↗