Triathlon 5537-G-211-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327287929), received between Nov 29, 2021 and Mar 19, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 16, 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.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  REVISION R TKA DUE TO INFECTION. ALL ORIGINAL IMPLANTS WERE EXPLANTED AND ANTIBIOTIC SPACER WAS PLACED TODAY. NO ADDITIONAL DETAILS TO BE REPORTED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 24636634 ↗
• InjuryJun 27, 2024Use of Device Problem; Use of Device Problem

  ON 5/9, I WAS IN A TOTAL KNEE. THIS CASE WAS A MAKO CASE. THE IMPLANTS WE CUT FOR WERE A SIZE 2 RIGHT PS FEMUR AND A SIZE 3 UNIVERSAL BASEPLATE. I PICKED UP THE STRYKER IMPLANTS AND READ THEM AND AT THE SAME TIME SHOWED THE DOCTOR. HE AGREED WITH THE IMPLANTS AND SAID IT WAS OK TO OPEN THEM. I READ A SIZE 2 RIGHT PS FEMUR, 3 UNIVERSAL BASEPLATE, 32 ASYMMETRIC PATELLA AND A 2X11 TS POLY, AND EXPIRATIONS FOR ALL IMPLANTS. I OPENED THE OUTER PACKAGING AND HANDED THE IMPLANTS TO THE NURSE WHO THEN AGAIN READ OUT THE SIZES AS SHE DROPPED THEM ON THE BACK TABLE FOR THE SCRUB TECH TO ASSEMBLE. WE WENT THROUGH IMPLANTING AND DOCTOR SAID THE KNEE FELT GREAT THROUGH THE FULL ROM. I THEN SENT THE BILLING. BILLING CALLED ME A FEW HOURS LATER AND ASKED IF I HAD MADE A MISTAKE AND PUT A 2X11 TS POLY IN ON ACCIDENT OR IF IT WAS A 3X11 TS POLY. I WENT BACK AND LOOKED AT THE BILLING AND SAW THIS ERROR. FROM THAT POINT BILLING CONTACTED DOCTOR AND TOLD HIM THE SITUATION AND MADE HIM AWARE OF IT. DOCTOR LATER ON IN THE DAY, AFTER THAT PHONE CALL DECIDED HE WAS GOING TO GO BACK AND REVISE THE KNEE TO PUT IN THE PROPER POLY SIZE (3X11 TS POLY). THE REVISION TOOK PLACE THE MORNING OF 5/11 WHERE BILLING

  Patient problems: Insufficient Information

  MAUDE report 19629176 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISED A TS INSERT DUE TO INFECTION OF A LEFT KNEE. ORIGINAL SURGERY WAS A REVISION OF A PRIMARY COMPETITOR KNEE." REP PROVIDED USAGE SHEETS FROM CURRENT AND PRIOR SURGERIES AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 14881820 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DOING POLY SWAP." PATIENT WAS REVISED FROM A 2X11 TS INSERT TO A 2X9 TS INSERT. SPOKE TO REP: PATIENT'S RIGHT KNEE WAS REVISED DUE TO STIFFNESS. CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 12888062 ↗

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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 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-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-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