Triathlon 5537-G-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327027327), received between Aug 9, 2019 and Sep 1, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY IN FLEXION AND EXTENSION. A 5X16 TS INSERT WAS REVISED TO A 5X19 TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15333238 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A FEMORAL COMPONENT WITH 4 AUGMENTS AND STEM (IMPLANTED (B)(6) 2018) AND INSERT (IMPLANTED (B)(6) 2019, REPORTED IN PI (B)(4)) WERE REVISED. REP PROVIDED REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11340294 ↗
• InjuryMar 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC ANTIBIOTIC SPACER WAS PLACED. REP PROVIDED THE PRIMARY AND REVISION (SPACER) USAGE SHEETS, EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9882267 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 5X16 TS INSERT WAS SWAPPED FOR ANOTHER 5X16 TS INSERT. REP WAS NOT PRESENT FOR THE PROCEDURE, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9728245 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 5X16 TS INSERT WAS SWAPPED FOR ANOTHER 5X16 TS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9728029 ↗
• InjuryOct 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S KNEE WAS REVISED DUE TO BLOODBORNE INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED). A POLY SWAP OF A 5 X 16 TS INSERT WAS PERFORMED. REP PROVIDED USAGE SHEETS FROM CURRENT AND PRIOR PROCEDURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9202378 ↗
• InjuryAug 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REQUIRED A WASHOUT OF A REVISED KNEE. POLY INSERT WAS EXPLANTED IN ORDER TO MAKE IRRIGATION OF THE JOINT EASIER. REPLACEMENT INSERT WAS IMPLANTED. UPDATE 16/JULY/2019: AS REPORTED IN HOW WAS ISSUE NOTICED "PATIENT SOUGHT TREATMENT FOR PAIN AND SWELLING". AS REPORTED IN ADVERSE CONSEQUENCES DETAILS: "PATIENT REQUIRED I & D".

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8878690 ↗