GAMMA 3525-0380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540375759), received between Apr 25, 2019 and Dec 10, 2025 — classified as 7 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO NECROSIS OF THE PATIENT'S NATIVE FEMORAL HEAD. A GAMMA3 NAIL (WITH 1 LAG SCREW AND 1 DISTAL SCREW) WAS REMOVED AND THE PATIENT WAS CONVERTED TO A TOTAL HIP. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Necrosis

  MAUDE report 23772272 ↗
• InjuryDec 3, 2025Fracture; Fracture

  AS REPORTED: "NAIL FAILURE AT INTERSECTION NAIL-LAG SCREW. APPROX. 4 MONTHS AFTER IMPLANTATION. THE PATIENT WAS REOPERATED ON (B)(6) 2025."

  Patient problems: Insufficient Information

  MAUDE report 23707095 ↗
• InjuryMar 17, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A NAIL IMPLANTED, WHICH BROKE AND WAS REMOVED.

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

  MAUDE report 21625918 ↗
• InjuryJul 27, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA3 NAIL (3525-0360S). "THE PATIENT WAS TREATED EXTERNALLY FOR A PER/SUBTROCHANTERIC LEFT FEMUR FRACTURE ON (B)(6) 2021 WITH A GAMMA NAIL. DURING THE CONSULTATION (B)(6) 2022, THE IMPLANT FRACTURE WAS DIAGNOSED AND THE PATIENT WAS ADMITTED TO HIP CLINIC AT BALGRIST UNIVERSITY HOSPITAL FOR FURTHER TREATMENT. HERE THE INDICATION FOR REVISION WAS GIVEN IN CASE OF SYMPTOMATIC PSEUDARTHROSIS. IF THE BONE FAILED TO HEAL AND THE IMPLANT FRACTURED, THE INDICATION FOR REVISION WAS GIVEN. THE INDICATION FOR REVISION WAS GIVEN AND THE PATIENT HAD TO UNDERGO SURGERY ON (B)(6) 2022."

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

  MAUDE report 15112656 ↗
• InjuryNov 24, 2021Break; Fracture; Break; Fracture

  AS REPORTED: "FRACTURE OF GAMMA NAIL AT THE FEMORAL NECK SCREW (LEFT THIGH) PAIN SINCE END OF (B)(6) 2021. THE PATIENT REQUIRED A REVISION SURGERY."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 12867650 ↗
• InjuryMar 4, 2021Malposition of Device; Malposition of Device

  AS REPORTED: "MEDIAL MIGRATION OF GAMMA LAG SCREW INTO PATIENT¿S PELVIS. REVISION THA SCHEDULED THE (B)(6) 2021 TO REMOVE LAG SCREW AND REPLACE HIP."

  Patient problems: Failure of Implant; Hip Fracture

  MAUDE report 11411534 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem

  IT'S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT THE PLAINTIFF WAS INJURED BY A STRYKER GAMMA NAIL ON (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 8553342 ↗