Triathlon 5565-S-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026771), received between Aug 14, 2019 and Jun 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Degraded; Loss of Osseointegration; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER REPORTED THAT: "FRACTURE (B)(6) OF THE TIBIAL AND FEMORAL STEMS LESS THAN TWO YEARS AFTER PROSTHESIS PLACEMENT. DURING REVISION SURGERY, FRACTURE OF THE IMPLANTS AND VERY SIGNIFICANT METALLOSIS (E1618) WITHIN THE KNEE WERE OBSERVED. IMPLANTATION DATE: (B)(6), 2024; DATE OF EXPLANTATION: (B)(6) 2026. IMPLANTED MEDICAL DEVICES: - 1 PG DEMI CALE TRIATHLON TS T2 5MM DM/GL (STRYKER FRANCE): REF. 5545-A-202, LOT NO. ERJVK2A, EXPIRY DATE 07/12/2026 - 1 PG REVIS EMBASE TIBIA TRIATHLON TS T2 (STRYKER FRANCE): REF. 5521-B-200, BATCH NO. O4G9RB, EXPIRY DATE 11/19/2028 - 1 PG QUILLE ANCR TRIATHLON TS 12X100MM (STRYKER FRANCE): REF. 5565-S-012, BATCH NO. 0131966D, EXPIRY DATE 12/20/2027 - 1 PG QUILLE ANCR TRIATHLON TS 15X100MM (STRYKER FRANCE): REF. 5565-S-015, BATCH NO. 0086223A, EXPIRY DATE 03/24/2024 - 1 PG REVIS FEMOR 2COND CIM TRIATHLON TS DTE T2 STEM (STRYKER FRANCE): REF. 5512F202, BATCH NO. L7T4U, EXPIRY DATE 07/19/2028 1 PG CALE FEMOR DIST TRIATHLON TS DTE T2 10MM (STRYKER FRANCE): REF. 5541-A-202, BATCH NO. EYS9G, EXPIRY DATE 09/23/2024 - 1 PG CALE FEMOR DIST TRIATHLON TS DTE T2 15MM (STRYKER FRANCE): REF. 5542-A-202, BATCH NO. EYR9

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology; Osteolysis

  MAUDE report 25651634 ↗
• InjuryAug 14, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  REVISION LEFT TOTAL KNEE REPLACEMENT. REMOVED TRIATHLON UNIVERSAL BASEPLATE & FLUTED STEM & PS INSERT FOR LOOSENING. REVISED WITH TRIATHLON UNIVERSAL BASEPLATE, CEMENTED TIBIAL STEM & TS INSERT. PREVIOUS REVISION SURGERY CONDUCTED AT (B)(6) IN (B)(6) 2014.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8892301 ↗