GAMMA 3525-1320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252274261), received between Apr 22, 2020 and Sep 17, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "THE GAMMA3 NAIL BROKE."

  Patient problems: Insufficient Information

  MAUDE report 23076717 ↗
• InjuryJan 28, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  THE CUSTOMER REPORTED THAT: "THE PATIENT UNDERWENT SURGERY ON (B)(6) 2024 FOR A GAMMA NAIL OF THE LEFT FEMUR (STRYKER). SINCE THE AFTERNOON OF (B)(6) 2024, SHE HAD BEEN EXPERIENCING PROGRESSIVE PAIN IN HER LEFT HIP. ON THE NIGHT OF (B)(6) 2024, DURING A TRANSFER TO THE TOILET, THE PATIENT DESCRIBED A ROTATING MOVEMENT OF THE HIP WITH AN AUDIBLE AN AUDIBLE CRACK. THE PAIN MADE IT IMPOSSIBLE TO STAND ON THE FLOOR. DURING SURGERY ON (B)(6) 2024, THE FEMORAL NAIL WAS FOUND TO HAVE RUPTURED."

  Patient problems: Pain

  MAUDE report 21256688 ↗
• InjuryJan 4, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN GAMMA NAIL, 2 MONTHS POST-SURGERY. NEED A SECOND MEDICAL PROCEDURE. REVISION OF GAMMA NAIL + U-BLADE COLUMN SCREW." UPDATE: WHEN WALKING FROM TOILET TO THE KITCHEN THE PATIENT SUFFERED ACUTE SEVERE PAIN. SHE HAD TO SIT DOWN AND COULD NO LONGER LOAD THE LEG.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 13156511 ↗
• InjurySep 3, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 3 MONTHS AFTER IMPLANTATION OF A PROXIMAL FEMUR NAIL, THE MATERIAL BROKE. ADDITIONAL INFORMATION RECEIVED: "THE PATIENT PRESENTED TO OUR ORTHOPEDIC TRAUMA SURGERY DEPARTMENT ON (B)(6) 2021 WITH INCREASING SYMPTOMS AND STATUS AFTER IMPLANTATION OF THE ABOVE PRODUCT. BY MEANS OF CT ((B)(6) 2021) A FRACTURE OF THE NAIL AT THE LEVEL OF THE THIGH SCREW PENETRATION COULD BE DETECTED. ACCORDING TO THE PATIENT, SHE ALREADY NOTICED A CRACKING DURING THE REHABILITATION STAY WITH AN INCREASE IN PAIN. IN THE COURSE OF THE SUBSEQUENT X-RAY CONTROL, NO COMPLICATIONS COULD BE DETECTED. CONSEQUENCES: FAILURE OF THE BONE FRACTURE TO HEAL SUBTROCHANTERICALLY, REVISION WITH COMPLETE REMOVAL OF THE MARROW AND RE-IMPLANTATION OF A LONG INTRAMEDULLARY NAIL OSTEOSYNTHESIS ON (B)(6) 2021. ANOTHER REHABILITATION MEASURES."

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

  MAUDE report 12421434 ↗
• InjuryApr 22, 2020Fracture; Fracture

  IT WAS REPORTED, AFTER X-RAYS, IT WAS DISCOVERED, 4 MONTHS AFTER THE IMPLANTATION, THE BREAKAGE OF THE NAIL, AT LAG SCREW INTERSECTION AND A TOTAL HIP REPLACEMENT HAS BEEN PERFORMED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9988705 ↗