Triathlon 5571-S-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327014976), received between Jan 8, 2019 and Aug 10, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Corroded” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  FEMORAL STEM DISASSOCIATED FROM THE FEMORAL COMPONENT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15204390 ↗
• InjuryFeb 12, 2020Fracture; Fracture

  REVISED BECAUSE STEM EXTENDER BROKE AT THE JUNCTION OF EXTENDER TO IMPLANT UPDATE: "OCCURRED BETWEEN EXTENDER AND RIGHT FEMORAL COMPONENT. NO OTHER ALLEGATIONS".

  Patient problems: Injury

  MAUDE report 9702668 ↗
• InjurySep 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA- OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8982223 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6) 2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8826038 ↗
• InjuryJan 8, 2019Corroded; Material Deformation; Corroded; Material Deformation

  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 ENG

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

  MAUDE report 8229580 ↗