GAMMA 8525-0340SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327474480), received between Jan 16, 2024 and Jun 23, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (5 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.

• InjuryJun 23, 2026Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO THE LAG SCREW OF THE GAMMA NAIL MIGRATING MEDIALLY INTO THE PATIENT'S ACETABULUM. REP CONFIRMED NO TRAUMA WAS REPORTED TO HIM. THE NAIL AND SCREWS WERE REMOVED, AND THE PATIENT WAS CONVERTED TO A THA USING A RESTORATION MODULAR STEM CONSTRUCT, TRIDENT II SHELL WITH SCREWS, AND AN ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Perforation

  MAUDE report 25595830 ↗
• InjuryMay 4, 2026Fracture

  AS REPORTED: "A GAMMA 4 LONG NAIL WAS INSERTED FOR A SUBTROCHANTERIC FRACTURE AT ANOTHER HOSPITAL. ON (B)(6) 2026, THE NAIL FRACTURED. SINCE THE PATIENT WAS NO LONGER ABLE TO WALK BY THIS NAIL FRACTURE, THE REVISION SURGERY TO REMOVE THE NAIL AND PERFORM BHA WAS DONE ON (B)(6) 2026."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25070607 ↗
• InjurySep 15, 2025Break; Fracture; Break; Fracture

  AS REPORTED: PATIENT WITH GAMMA4 IMPLANT. THE PATIENT FELL AND RE-FRACTURED THE FEMUR, REQUIRING REOPERATION. THE GAMMA4 WAS ALSO BROKEN. THE REOPERATION USED AN IMPLANT FROM ANOTHER COMPANY."

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 23053528 ↗
• InjuryJul 16, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE GAMMA4 LONG NAIL WAS IMPLANTED IN LEFT FEMUR OF THE PATIENT ON (B)(6) 2024. FRACTURE OF PROXIMAL PART OF THE NAIL WAS CONFIRMED ON (B)(6) 2025. REVISION SURGERY WAS PLANNED ON (B)(6) 2025."

  Patient problems: Insufficient Information

  MAUDE report 22520054 ↗
• InjuryApr 24, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "NAIL BREAKAGE AT THE LAG SCREW HOLE. GAMMA4 WAS REMOVED AND REPLACED WITH AN INTRAMEDULLARY NAIL FROM ANOTHER COMPANY."

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21902815 ↗
• InjuryNov 23, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED, THE PRIMARY SURGERY WAS PERFORMED AND THE NAIL WAS IMPLANTED IN THE PATIENT'S LEFT FEMUR ON (B)(6) 2024. ON (B)(6) 2024, THE NAIL FRACTURE WAS FOUND. THUS, THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20766493 ↗
• InjuryJan 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023. BECAUSE THE BONE WAS HIGHLY FRAGILE WITH A STRONG CURVE, A NAIL OF THE PROPER LENGTH WAS INSERTED, BUT THE NAIL TIP PROTRUDED FROM THE BONE (AND A LITTLE SCREW). THIS WAS DISCOVERED LATER WHEN THE PATIENT WAS CHECKED BY CT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. THE SCREW WAS REPLACED WITH A CONDYLAR SCREW."

  Patient problems: Perforation

  MAUDE report 18519623 ↗