Triathlon 5537-G-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027402), received between May 22, 2018 and Sep 3, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A TRIATHLON TS INSERT PERFORMING AN I&D DUE TO SIGNS OF INFECTION. HE CHANGED FROM A SZ 6X13 TO A 6X16. THIS PATIENT ALREADY WAS REVISED FROM AN ARTHREX TOTAL KNEE TO A SPACER DUE TO INFECTION. THE TRIATHLON TS WAS IMPLANTED ON (B)(6) 2019. UPDATE 06/AUGUST/2019: SPOKE TO REP. ORIGINAL IMPLANT SURGERY (B)(6) 2019 TOOK PLACE IN THE SAME HOSPITAL AS REVISION. REP PROVIDED USAGE SHEETS FROM PRIMARY STRYKER IMPLANT AND REVISION, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8955414 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED OR INFECTING MICROORGANISM IDENTIFIED). SURGEON PERFORMED A POLY SWAP.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8449232 ↗
• InjuryJun 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED AFTER DISLOCATION (REP REPORTED THAT REASON/ CAUSE UNKNOWN). SOFT TISSUE REPAIR WAS PERFORMED AND PATIENT WAS REVISED TO A THICKER POLY.

  Patient problems: Injury; Joint Dislocation; Tissue Damage

  MAUDE report 7567060 ↗
• InjuryMay 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT COMPLAINED OF PAIN IN THEIR KNEE AFTER A TOTAL JOINT WAS PERFORMED APPROXIMATELY 3 YEARS AGO. PATIENT REQUIRED REVISION KNEE SURGERY TO REPLACE INSERT WITH A LESS CONSTRAINING PS INSERT.

  Patient problems: Injury; Pain

  MAUDE report 7532897 ↗