GAMMA 3425-1420SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252273868), received between Dec 28, 2022 and Mar 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2023Break; Fracture; Break; Fracture

  ACCORDING TO THE USER REPORT THE PATIENT WAS ADMITTED AS AN IN PATIENT AFTER CONSULTATION WITH THE (B)(6), WHERE THE PATIENT WAS CURRENTLY HOSPITALIZED AFTER A PATHOLOGICAL PROXIMAL FEMUR FRACTURE ON THE RIGHT WITH OSTEOLYSIS AND INSERTION OF AN OVERLONG GAMMA NAIL ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT SUDDENLY FELT PAIN IN HIS RIGHT THIGH FOR THE FIRST TIME WHILE WALKING (WITHOUT TRAUMA) AND WAS NO LONGER ABLE TO WALK. PAIN HAD ALSO INCREASED IN THE COURSE. IMAGING SHOWED FRACTURE OF THE FEMORAL INTRAMEDULLARY NAIL WITH MARKED VARICOSE TILT AND ROTATION OF THE PROXIMAL PORTIONS OF THE MATERIAL. SUCCESSFUL REVISION SURGERY WITH RESECTIONS EN BLOC PROXIMAL FEMUR AND RECONSTRUCTION VIA MUTARS PROSTHESIS "PROXIMAL FEMUR REPLACEMENT" 80 MM RECONSTRUCTION LENGTH (CEMENTLESS STEM COMPONENT 18 MM DIAMETER,70 MM PROXIMAL FEMUR PART, 52 MM INNER DIAMETER DUO HEAD WITH 32 MM METAL HEAD INNER DIAMETER (SHORT), TROCHANTERIC REFIXATION) ON (B)(6) 2023. PATIENT PASSED AWAY WHILE HE WAS UNDER PALLIATIVE CARE.

  Patient problems: Cancer; Failure of Implant; Implant Pain; Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 16659332 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I TAKE CARE OF A PATIENT AFTER OSTEOSYNTHESIS OF THE RIGHT FEMUR. THE OPERATION WAS CARRIED OUT IN (B)(6) 2019. THE PATIENT CAME TO OUR DEPARTMENT FOR FEMORAL HEAD NECROSIS WITH OSTEOMYELITIS AND SOFT TISSUE ABSCESS OF THE THIGH. WE NEED TO EXTRACT THE IMPLANTS. THIS IS A STRYKER 3 GAMMA NAIL SYSTEM. THE OPERATION IS SCHEDULED FOR (B)(6) 2022."

  Patient problems: Abscess; Necrosis; Osteomyelitis

  MAUDE report 16061209 ↗