Triathlon 5532-G-819Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327046380), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  LETTER RECEIVED FROM PATIENT'S LAWYERS ADVISING THE STRYKER TS TRIATHLON KNEE REPLACEMENT IS "DEFECTIVE AND MATERIALLY CONTRIBUTED TO ON GOING LEFT LOWER LIMB PROBLEMS INCLUDING THE DEVELOPMENT OF A PSEUDO-TUMOUR". PATIENT IS REPORTS 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) YEAR OLD 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 ENGAGE

  Patient problems: Cyst(s); Fibrosis; Inadequate Osseointegration; Injury

  MAUDE report 8229280 ↗