Triathlon 5546-A-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026504), received between Aug 15, 2018 and Jan 8, 2019 — 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.

• InjuryJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  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.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 8229019 ↗
• InjuryAug 15, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO A LOOSE TIBIA. A BASEPLATE, PS INSERT, 2 AUGMENTS, OFFSET, AND STEM WERE REVISED TO A TS CONSTRUCT WITH 3 AUGMENTS.

  Patient problems: Injury

  MAUDE report 7786101 ↗