Triathlon 5560-S-212Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327026542), received between Jan 8, 2019 and Jan 14, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2024Loss of Osseointegration; Loss of Osseointegration

  DR. REVISED A RIGHT TRIATHLON TS TO A NEW TS DUE TO PATIENT COMPLAINING OF PAIN. BOTH FEMUR AND TIBIA WERE LOOSE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18509835 ↗
• InjuryNov 15, 2019Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  MEDICAL RECORDS PROVIDED FOR LEGAL PI 2144066 HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A THIRD REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6) 2018 DUE TO LOOSENING ON TIBIAL SIDE (BASEPLATE/TIBIAL STEM/AUGMENT) LOOSENING. AN INTRAOPERATIVE FRACTURE OF THE TIBIA WAS ALSO REPORTED TO HAVE OCCURRED DURING THIS REVISION SURGERY ON (B)(6) 2019. EXCERPT FROM MEDICAL REVIEW: "EARLY LOOSENING OF BASEPLATE WITH STEM EXTENDER AND AUGMENT OCCURRED REQUIRING A THIRD REVISION SURGERY." "REMOVING ALL BONE CEMENT FROM THE TIBIAL CANAL WAS AGAIN DIFFICULT AND REQUIRED MAKING A WINDOW IN THE TIBIAL CORTICAL BONE FOR DISTAL ACCESS TO THE BONE CEMENT FOR REMOVAL. LATERAL AND POSTERIOR ¿CRACKS¿ DEVELOPED IN THE TIBIAL CORTEX DURING THESE DIFFICULT MANOEUVRES TO REMOVE ALL BONE CEMENT."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury

  MAUDE report 9328887 ↗
• InjurySep 10, 2019Fracture; Fracture

  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 8981897 ↗
• InjuryJan 8, 2019Corroded; Loss of Osseointegration; Corroded; Loss of Osseointegration

  LETTER RECEIVED FROM PATIENT'S LAWYERS 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 REPORTS LEFT KNEE PROBLEMS FOLLOWING SURGERY ON THE (B)(6) 2012. PLEASE SEE COMMUNICATION LOG FOR DETAILS REGARDING ADDITIONAL INFORMATION.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8229285 ↗