Triathlon 5537-G-316-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327288179), received between Jun 13, 2022 and Oct 9, 2024 — classified as 5 injuries.

7 other recalls cover devices cleared under the same FDA submission (K172634); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV RTKA FOR INFECTION- STATIC SPACER GOING IN." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 20413481 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION WAS PERFORMED. AS REPORTED: "PATIENT STATUS POST RIGHT TOTAL KNEE I&D / POLY SWAP COMPLETED TODAY DUE TO INFECTION. NO ADDITIONAL INFORMATION PROVIDED BY THE FACILITY."

  Patient problems: Unspecified Infection

  MAUDE report 18158115 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "RIGHT TOTAL KNEE. REVISION WAS DONE DUE TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL." ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 15337489 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PATIENT HAD A 2 STAGE REVISION DUE TO INFECTION. PATIENT IS INQUIRING IF THE STRYKER IMPLANTS USED IN THE 2ND STAGE REVISION ARE SUBJECT TO A RECALL. PATIENT DID NOT REPORT ANY ISSUES AFTER REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 15154547 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SEVERE RIGHT TKA PAIN AND EFFUSION. WORKUP FOR INFECTION WAS POSITIVE. PATIENT OPTED FOR A 2-STAGE REVISION TKA.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14674562 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E