Triathlon 5537-G-116Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026979), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryNov 13, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "ON (B)(6) 2020 PATIENT REPORTED EXCESSIVE KNEE PAIN, MORE SPECIFICALLY WORSENING LEFT THIGH PAIN THAT WORSENS WITH INCREASED ACTIVITY. BASED ON X-RAYS, THERE¿S A POSSIBLE RADIOLUCENCY AROUND THE FEMORAL STEM, HOWEVER THE PATIENT NEEDS TO HAVE A BONE SCAN AND POSSIBLE ASPIRATION TO FURTHER IDENTIFY THE PROBLEM AND SOURCE OF PAIN. PATIENT HAD A FAMILY EMERGENCY AND RESCHEDULED BONE SCAN TO LATER DATE." UPDATE 04/NOVEMBER/2022 WG: SUBJECT PRESENTED WITH PAIN AND HER EVALUATION WAS CONSISTENT WITH LOOSENING OF HER FEMORAL COMPONENT. LEFT KNEE REVISION (B)(6) 2022.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10835248 ↗