Triathlon 5571-S-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327014983), received between Jan 8, 2019 and Jun 16, 2022 — classified as 2 injuries.

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

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 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PT. PRESENTED WITH THIGH PAIN, IMAGING WAS INDICATIVE OF A LOOSE FEMORAL IMPLANT FOLLOWING A KNEE-REVISION "BACK IN OCTOBER OF 2017". SURGEON RULED OUT INFECTION AND DETERMINED THE FEMORAL CONSTRUCT WAS ASEPTICALLY LOOSE. HE PERFORMED A REVISION OF THE FEMORAL IMPLANTS, LEAVING THE TIBIAL BASEPLATE AND STEM IN-SITU. NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP. NO WEAR OR DAMAGE WAS NOTED INTRA-OPERATIVELY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14723106 ↗
• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  LETTER RECEIVED REGARDING A PATIENT; ADVISING THE STRYKER TS TRIATHLON KNEE REPLACEMENT IS "DEFECTIVE AND MATERIALLY CONTRIBUTED TO... ONGOING LEFT LOWER LIMB PROBLEMS INCLUDING THE DEVELOPMENT OF A PSEUDO-TUMOUR". PATIENT IS REPORTING LEFT KNEE PROBLEMS FOLLOWING SURGERY ON "THE" (B)(6) 2012. PLEASE SEE COMMUNICATION LOG FOR DETAILS REGARDING ADDITIONAL INFORMATION. AS PER OP REPORT: COMMENTS: TRIATHLON TS CEMENTED REVISION KNEE FROM AN (B)(6) MALE REVISED AFTER 4 YEARS DUE TO OSTEOLYSIS AND ALVAL (PSEUDOTUMOUR) IS PRESENTED FOR ANALYSIS. HIGH ACTIVITY LEVEL AND MEDIAL BONE LOSS AROUND THE TIBIAL COMPONENT ARE CONSIDERED CONTRIBUTORY FACTOR TO FAILURE OF THE DEVICE. FEMORAL COMPONENT: A COMBINATION OF BONE AND FIBROUS TISSUE ONTO CEMENT MANTLE INDICATING A WELL FIXED COMPONENTS - NUMEROUS LONGITUDINAL SCRATCHES ON BEARING SURFACE. THREADED BOSS COVERED WITH ORGANIC MATERIAL AND SHOWING WEAR ON THE SURFACE IN CONTACT WITH STEM EXTENDER (FIG. 1). FEMORAL STEM EXTENDER: CORROSION AND WEAR IN THE BASE OF THREADED TRUNNION FROM UNEVEN ENGAGEMENT WITH FEMORAL COMPONENT BOSS COVERED WITH ORGANIC MATERIAL (FIG. 2). FEMORAL STEM: WEAR IN THE BASE OF THREADED TRUNNION FROM UNEVEN ENGAGEMENT

  Patient problems: Injury

  MAUDE report 8226157 ↗