Triathlon 5531-G-713Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327046014), received between Jun 14, 2018 and Feb 27, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2020Difficult to Insert; Difficult to Insert

  MR USED A TRIATHLON INSERT ON TUESDAY, THAT WOULDN¿T SIT PROPERLY DESPITE REPEATED ATTEMPTS TO INSERT IT; A DUPLICATE WAS OPENED THAT SAT PROPERLY IMMEDIATELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9764843 ↗
• InjuryMay 1, 2019Unstable; Unstable

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY RIGHT TOTAL KNEE REPLACEMENT ARTHROPLASTY."

  Patient problems: Injury

  MAUDE report 8568696 ↗
• InjuryOct 9, 2018Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SURGEON REPORTED THAT PATIENT DEVELOPED RECURRENT EFFUSIONS FOLLOWING TOTAL KNEE REPLACEMENT WITH STRYKER TRIATHLON CEMENTLESS COMPONENTS. DUE TO MULTIPLE PATIENT ALLERGIES, PATIENT WAS THEN TESTED FOR METAL ALLERGIES, WHICH CAME BACK POSITIVE FOR ALLERGY TO NICKEL. REVISION WAS SCHEDULED AND PERFORMED ON (B)(6) 2018, REMOVING FEMUR, POLY INSERT, AND TIBIAL COMPONENT. TRITANIUM PATELLA WAS RETAINED. REVISION WITH NICKEL FREE IMPLANTS FROM [COMPETITOR] WAS PERFORMED.

  Patient problems: Injury; Reaction

  MAUDE report 7948806 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF PATIENT'S LEFT KNEE ON (B)(6) 2013. IT WAS REPORTED THROUGH THE SUBMISSION OF FIVE IMPLANT SHEETS ON (B)(6) 2018 THAT PATIENT'S LEFT KNEE WAS REVISED ON (B)(6) 2013. A CR FEMUR (IMPLANTED (B)(6) 2010), BASEPLATE, STEM AND 2 DOSES OF CEMENT (IMPLANTED (B)(6) 2011), AND A CS INSERT (IMPLANTED (B)(6) 2011) WERE REVISED TO A TRIATHLON TS CONSTRUCT CONSISTING OF A FEMUR, 2 STEMS, UNIVERSAL BASEPLATE, AND INSERT.

  Patient problems: Injury

  MAUDE report 7897728 ↗
• InjuryJun 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "ALL 4 TRIATHLON COMPONENTS REMOVED FOR INFECTION. PATIENT RECEIVED TEMPORARY CEMENT SPACER UNTIL INFECTION CLEARS."

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7601969 ↗