NA 1896-5037SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540382337), received between Nov 29, 2016 and Sep 16, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 reports).

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.

• InjurySep 16, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT PRIMARY SURGERY FOR A TROCHANTERIC FRACTURE WAS PERFORMED ON (B)(6) 2021. ON AN UNKNOWN DATE, ONE DISTAL SCREW WAS REMOVED DUE TO POSTOPERATIVE PSEUDARTHROSIS AND DYNAMIZATION WAS ATTEMPTED, BUT THERE WAS NO BONY FUSION AND THE NAIL AND DISTAL SCREW BROKE OFF. REVISION SURGERY TO THA WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15439806 ↗
• MalfunctionMay 21, 2021Fracture; Fracture

  IT WAS REPORTED: "WHEN THE LONG GAMMA IMPLANTED PROCEDURE, THE SCREW WAS INSERTED AS USUAL, BUT IT BROKE IN THE MIDDLE. ONLY THE SHAFT WAS REMAINED INSIDE THE PATIENT BODY. SINCE IT WAS A HARD BONE".

  Patient problems: Foreign Body In Patient

  MAUDE report 11862085 ↗
• InjuryJan 8, 2020Fracture; Fracture

  THE FOLLOWING EVENT WAS REPORTED BY THE END USER TO THE (B)(6) COMPETENT AUTHORITY ((B)(6)); BREAKAGE OF THE LOCKING SCREWS. REVISION SURGERY ON (B)(6) 2019.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9567050 ↗
• InjuryJun 25, 2019Device Dislodged or Dislocated

  GAMMA3 PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014. THIS TIME CUTOUT OF THE LAG SCREW WAS FOUND. IT IS UNKNOWN WHEN THE CUTOUT WAS OCCURRED. THE PATIENT HAS FELT PAIN BUT IS ABLE TO WALK. REVISION SURGERY TO THA WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8732823 ↗
• InjuryApr 4, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GAMMA3 U-LAG SCREW SURGERY ON (B)(6) 2019. AFTER THE SURGERY, THE CUTOUT OF U-LAG SCREW AND THE BENDING OF U-BLADE WERE CONFIRMED. THEN GAMMA3 EXTRACTION AND REVISION TO THA WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8483026 ↗
• InjuryNov 29, 2016Failure To Adhere Or Bond; Fracture

  ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 NAIL AND U-LAG SCREW. AFTER SURGERY, THE PATIENT FELT THE PAIN. THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE FRACTURE PART WAS NON-UNION. THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY BY THE BONE GRAFT AND THE DISTAL SCREW REMOVE ON (B)(6) 2016.

  Patient problems: Pain

  MAUDE report 6133814 ↗