TRIATHLON 5612-X-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327560329), received between Oct 7, 2024 and Oct 7, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (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.

• InjuryOct 7, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  THIS PI IS FOR THE REVISION OF THE INSERT. PATIENT DISLOCATED HIS POLY. DR. REDUCED IT A WEEK OR SO PRIOR TO THE REVISION. UPON REMOVAL OF THE POLY SIGNIFICANT WEAR WAS FOUND ON THE UNDERSIDE. DR. DOES NOT BELIEVE IT TO BE AN IMPLANT MALFUNCTION BUT MORE SO ON THE LACK OF PATIENT COMPLIANCE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20390565 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR THE REDUCTION PRIOR TO REVISION. PATIENT DISLOCATED HIS POLY. DR. REDUCED IT A WEEK OR SO PRIOR TO THE REVISION. UPON REMOVAL OF THE POLY SIGNIFICANT WEAR WAS FOUND ON THE UNDERSIDE. DR. DOES NOT BELIEVE IT TO BE AN IMPLANT MALFUNCTION BUT MORE SO ON THE LACK OF PATIENT COMPLIANCE.

  Patient problems: Joint Dislocation

  MAUDE report 20388727 ↗