Triathlon 5531-P-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327042306), received between Oct 9, 2020 and May 7, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Degraded; Material Erosion; Degraded; Material Erosion

  PATIENT VISITED OFFICE AND X-RAYS REVEALED AN ASYMMETRIC JOINT SPACE AND SUPPOSED TIBIAL BASEPLATE FRACTURE WITH POLY WEAR. PATIENT HAD REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19257848 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A POLY SWAP DUE TO AN INFECTION. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15613311 ↗
• MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED THAT THE "WIRE FROM INSERT LOCKING MECHANISM APPEARED OUT OF ITS PLACE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009525 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A WASHOUT AND EXCHANGE OF A 5X9 CS POLY FOR ANOTHER 5X9 CS POLY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 13423305 ↗
• InjuryAug 9, 2021Break; Break

  AS REPORTED: "THE PATIENT FELL AND RUPTURED THE CAPSULE REPAIR. THE BEARING WAS EXCHANGED SINCE THEY WERE BACK IN THE JOINT REPAIRING THE CAPSULE. NO OTHER INFORMATION IS AVAILABLE." SPOKE TO REP: CONFIRMED THAT THE MAKO BONE CUTS FROM THE PRIMARY SURGERY AND THE IMPLANT PLACEMENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S FALL. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. LEFT KNEE.

  Patient problems: Fall

  MAUDE report 12293472 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PATIENT HAD A RUPTURED CAPSULE AS THE RESULT OF A MOTOR VEHICLE ACCIDENT. AS THE SURGEON WAS REPAIRING THE CAPSULE, HE DECIDED TO PROPHYLACTICALLY EXCHANGE A 5X9 CS INSERT FOR ANOTHER 5X9 CS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 10654515 ↗