TRIGEN 71653436Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010548634), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 MONTHS AFTER A PRIMARY PROCEDURE WITH TRIGEN META-NAIL RETROGRADE FEMORAL NAIL TO TREAT A SIMPLE LONG BONE FRACTURE OF THE FEMUR, THE PATIENT EXPERIENCED SOME UNSPECIFIED FUNCTIONAL IMPAIRMENT AND PAIN. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE DISTAL LOCKING SCREW 24 MONTHS POSTOP AS IT WAS PROMINENT ((B)(4)) AND ANOTHER REVISION SURGERY TO REMOVE THE NAIL 33 MONTHS POSTOP DUE TO KNEE PAIN ((B)(4)). THE PATIENT'S UNION / CORRECTION WAS CONFIRMED RADIOGRAPHICALLY AT 8 MONTHS POSTOP. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 13052629 ↗