GAMMA 3425-3320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540406644), received between Jul 23, 2018 and Jul 23, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJul 23, 2018Appropriate Device Problem Term/Code Not Available

  IN THE FEMORAL TROCHANTER FRACTURE, A 13 MM GAMMA LONG WAS PREPARED. REAMING STARTED FROM 11 MM, REAMING TO 14 MM AND INSERTING A GAMMA LONG BUT IT STACKED. IT WAS FURTHER REAMED TO 15.5 MM AND INSERTED THE GAMMA BY HITTING WITH A HAMMER. AFTER PROXIMAL FIXATION AND DISTAL FIXATION, FEMORAL CONDYLAR FRACTURE WAS NOTED. COMPLETED THE PROCEDURE AND FIXED IT WITH GIBBS.

  Patient problems: Bone Fracture(s)

  MAUDE report 7712313 ↗