Triathlon 5551-L-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327049862), received between Jul 19, 2018 and Jun 30, 2025 — classified as 3 injuries.

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

• InjuryJun 30, 2025Fracture; Fracture

  PATIENT REPORT: "I AM CONTACTING YOU IN REGARD TO PATELLA IMPLANT THAT APPEARS TO HAVE A FRACTURE. THIS WAS IMPLANTED AT THE END OF (B)(6) 2025 - THERE HAS BEEN NO TRAUMA."

  Patient problems: Discomfort; Insufficient Information; Pain

  MAUDE report 22355948 ↗
• InjuryNov 15, 2024Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE RIGHT KNEE. AS REPORTED: "DR. IS ASKING FOR US TO DOCUMENT AN INSTANCE OF ASEPTIC LOOSENING FOR A PATIENT SHE OPERATED ON (B)(6) 2022. THE PATIENT HAD BILATERAL TKA AND IS NOW BEING REVISED ON BOTH SIDES FOR LOOSENING. SHE HAD SHARED THE IMPLANT INFORMATION AND ASKED THAT WE CHECK THE LOT NUMBERS FOR ANY RECALLS." NONE OF THE REPORTED IMPLANTS WERE SUBJECT TO RECALL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20693290 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED ON FDA MAUDE MW 5077850 " PT UNDERWENT AN ELECTIVE ARTHROPLASTY TOTAL KNEE IN 2018. THE PT HAD EVIDENCE OF A SURGICAL SITE INFECTION INVOLVING THE JOINT. THE JOINT FLUID AND TISSUE WERE CULTURED AND GREW MYCOBACTERIUM FORTUITUM. THE IMPLANTS USED WERE MANUFACTURED BY STRYKER MEDICAL. WE DO NOT KNOW IF THE STRYKER MEDICAL KNEE HARDWARE IS THE SOURCE FOR THIS INFECTION, BUT SINCE THIS IS AN EXTREMELY RARE EVENT AND POST-SURGICAL WOUND INFECTIONS HAVE BEEN REPORTED WITH IMPLANTS WE THOUGHT IT WOULD BE PRUDENT TO REPORT THIS INCIDENT"

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7703922 ↗