GAMMA 3066-0105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540596017), received between Jul 30, 2020 and Oct 24, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2023Material Deformation; Material Deformation

  AS REPORTED: "AFTER SURGERY, THE U-LAG SCREW CUT OUT THE FEMORAL HEAD WITH U-BLADE DEFORMATION AND THE REVISION SURGERY WAS PERFORMED."

  Patient problems: Failure of Implant; Perforation

  MAUDE report 17993863 ↗
• InjuryOct 18, 2021Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED: CUTOUT OF PROXIMAL FEMORAL RESTORATION WITH GAMMA3 U-BLADE, U-BLADE IS BENT, REMOVAL DIFFICULT.

  Patient problems: Failure of Implant; Hip Fracture

  MAUDE report 12647600 ↗
• InjuryJul 30, 2020Positioning Failure; Migration; Positioning Failure; Migration

  AS REPORTED: "DURING LAG SCREW DID NOT SLIDE, AND IT PENETRATED THE FEMORAL HEAD. THE SURGEON IT COULD BE DUE TO THE SET SCREW."

  Patient problems: Failure of Implant; Perforation

  MAUDE report 10348101 ↗