GAMMA 3125-1200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04546540375087), received between Aug 30, 2016 and Jul 8, 2026 — classified as 31 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (25 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Biocompatibility

  THE CUSTOMER REPORTED THAT "ON (B)(6) 2024: PLACEMENT OF A STERILE TITANIUM PROXIMAL FEMORAL NAIL AT (B)(6) HOSPITAL IN LE PUY-EN-VELAY FOR A FRACTURE OF THE RIGHT FEMUR. ON (B)(6) 2024: EPISCLERITIS DIAGNOSED BY OPHTHALMOLOGISTS. ON (B)(6) 2025: DIAGNOSIS OF ERYTHEMA NODOSUM MADE IN THE EMERGENCY DEPARTMENT OF (B)(6) DUE TO PAIN AND SWELLING IN THE LOWER EXTREMITIES, INITIALLY TREATED AS ERYSIPELAS. DIAGNOSIS OF SARCOIDOSIS-TYPE GRANULOMATOSIS CONFIRMED BY LYMPH NODE BIOPSY DUE TO THE PRESENTATION OF EPISCLERITIS, ERYTHEMA NODOSUM, AND MEDIASTINAL LYMPHADENOPATHY. (B)(6) 2025: INITIATION OF CORTICOSTEROID THERAPY AT 0.5 MG/KG/DAY OF PREDNISOLONE WITH GRADUAL TAPERING OVER 1 YEAR. DURING THE TAPERING PHASES, THE PATIENT DESCRIBED THE ONSET OF NONSPECIFIC SYMPTOMS SUCH AS: - HEAVINESS IN THE LEGS - NAUSEA - PAIN IN THE RIGHT LEG IF THE PATIENT PUTS HIS CELL PHONE IN THE RIGHT PANTS POCKET - ASTHENIA - DIFFICULTY CONCENTRATING - SHORTNESS OF BREATH - SWEATING - COUGHING OR SNEEZING WHEN APPLYING ALCOHOL-BASED DEODORANT OR CONSUMING ALCOHOL. IT SHOULD BE NOTED THAT THE PATIENT REPORTS A HISTORY OF REACTIONS TO METALS: BELT BUCKLES, JEANS BUTTONS, AND COSTUME JEWELRY AROUND THE AGE OF

  Patient problems: Hypersensitivity/Allergic reaction; Nausea; Pain

  MAUDE report 25752575 ↗
• InjuryFeb 17, 2026Fracture

  AS REPORTED: "APPROXIMATELY 6 WEEKS AFTER IMPLANTATION, THE GAMMA3 NAIL BROKE.PATIENT REQUIRED REVISION SURGERY."

  Patient problems: Insufficient Information

  MAUDE report 24369558 ↗
• InjuryJan 29, 2026Fracture

  AS REPORTED: "OSTEOSYNTHESIS OF PERTROCHANTERIC FEMORAL FRACTURE WITH GAMMA NAIL. INCREASING PAIN FOR APPROX. 4 WEEKS WITHOUT TRAUMA. NOW, WITH THE FRACTURE NOT HEALED, IMPLANT FAILURE/FRACTURE HAS OCCURRED IN THE AREA OF THE FEMORAL NECK SCREW GUIDE IN THE NAIL. PATIENT REQUIRED REVISION SURGERY."

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

  MAUDE report 24217868 ↗
• InjuryDec 17, 2025Fracture; Fracture

  AS REPORTED: "GAMMA3 NAIL FRACTURE IN THE AREA OF THE SHS. THE IMPLANT IS NO LONGER AVAILABLE."

  Patient problems: Insufficient Information

  MAUDE report 23833699 ↗
• MalfunctionDec 10, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT "INCORRECT DRILLING OCCURRED DURING DISTAL LOCKING OF A GAMMA NAIL (LENGTH 200 MM)." PRE-OPERATING TESTING AND FINAL IMAGING WERE CONDUCTED. THE SURGERY WAS COMPLETED USING THE FREE-HAND TECHNIQUE. THE ACTIVITY LEVEL OF THE PATIENT WAS NORMAL AND THE PATIENT WAS COMPLIANT TO MOBILIZATION INSTRUCTIONS FROM THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773176 ↗
• InjuryNov 24, 2025Fracture; Fracture

  AS REPORTED: "THE CUSTOMER CALLED TO REPORT A BROKEN GAMMA 3 NAIL. IMPLANTATION DATE: (B)(6) 2025 PLANNED REVISION: SCHEDULED FOR (B)(6) 2025."

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23639533 ↗
• InjuryJun 17, 2025Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  AS REPORTED: "THE PATIENT HAS A GAMMA NAIL WITH A U-BLADE AND THIS SHOULD BE REPLACED. THE NAIL IS BROKEN IN THE AREA WHERE THE FEMORAL NECK SCREW PASSES THROUGH. THE NAIL WAS REMOVED AND A NEW ONE WAS IMPLANTED."

  Patient problems: Insufficient Information

  MAUDE report 22235917 ↗
• InjuryJan 7, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "EXACTLY 4 MONTHS PREVIOUSLY, THE PATIENT HAD UNDERGONE OSTEOSYNTHESIS USING A GAMMA NAIL AS PART OF A SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR. AFTER AN UNCOMPLICATED AND TIMELY COURSE, THE PATIENT THEN PRESENTED TO THE HOSPITAL IN AN EMERGENCY FOUR MONTHS LATER. RADIOLOGY REVEALED A FRACTURE OF THE GAMMA NAIL IN THE AREA WHERE THE FEMORAL NECK SCREW WAS INSERTED. A REVISION WAS THEN PERFORMED. THE GAMMA NAIL WAS REMOVED AND A LONG STEM PROSTHESIS WAS IMPLANTED. SUBSEQUENT TIMELY AND NORMAL PROGRESSION."

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21093827 ↗
• InjuryNov 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "GAMMA NAIL IS BROKEN AT THE ENTRY POINT OF THE FEMORAL NECK SCREW. METAL REMOVAL NECESSARY." ON THE X-RAY ATTACHED IN THE INTAKE, WE SEE THAT ONE OF THE DISTAL LOCKING SCREW IS ALSO BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 20667708 ↗
• InjurySep 4, 2024Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA NAIL WHICH RESULTED IN THE PATIENT UNDERGOING A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 20136583 ↗
• InjuryJul 12, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  A NAIL BREAKAGE WAS REPORTED. A REVISION SURGERY IS REQUIRED. THE DATE OF REVISION IS NOT REPORTED.

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

  MAUDE report 19735685 ↗
• InjuryFeb 5, 2024Break; Fracture; Break; Fracture

  A BROKEN NAIL WAS DISCOVERED. THE NAIL HAD TO BE REMOVED. 2/5/2024 - ADDITIONAL INFORMATION RECEIVED. NAIL FRACTURE IN CONJUNCTION WITH DELAYED FRACTURE HEALING IN STATUS POST GAMMA NAIL OSTEOSYNTHESIS DUE TO SUBTROCHANTERIC FRACTURE OF THE RIGHT FEMUR.

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

  MAUDE report 18639771 ↗
• InjuryMar 6, 2023Break; Fracture; Device Dislodged or Dislocated; Break; Fracture; Device Dislodged or Dislocated

  AS REPORTED: "PAIN IN THE OPERATED AREA WITHOUT TRAUMA WITH SIGNIFICANT INCREASE IN THE COURSE. X-RAY DIAGNOSIS REVEALED SINTERING OF THE GAMMA NAIL WITH FRACTURE OF THE DISTAL LOCKING SCREW. PATIENT WAS OPERATED AGAIN."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 16491699 ↗
• InjuryDec 16, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A NAIL BROKE IN THE AREA OF THE FEMORAL NECK SCREW WHEN ATTEMPTING TO DRIVE THE NAIL OUT AFTER REMOVING THE LOCKING SCREW AND FEMORAL NECK SCREW. THERE WAS PROLONGED SURGERY TIME BECAUSE THE ACCESS IN THE TROCHANTER HAD TO BE ENLARGED AND ALSO A CONICAL EXTRACTOR HAD TO BE USED TO REMOVE THE REST OF THE REST OF THE BROKEN NAIL.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996807 ↗
• InjuryOct 7, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT GAMMA3 TROCHANTERIC NAIL BROKE. T2 FULLY THREADED LOCKING SCREW BROKE.

  Patient problems: Failure of Implant

  MAUDE report 15566273 ↗
• InjurySep 14, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PATIENT HAD A LEFT HIP SUBTROCHONTERIC FRACTURE. PATIENT ALSO HAD A PREVIOUS REVISION TOTAL KNEE WITH A LONG STEM ON THE FEMORAL COMPONENT. ON (B)(6) 2022 THE PATIENT WENT INTO OFFICE AND IT WAS NOTED ON X RAYS THAT THE FRACTURE HAD FALLEN SLIGHTLY INTO VARUS. STILL INTACT. A BROKEN NAIL CAN BE SEEN ON THE PICTURE. HE WAS TO BE ON 50% WEIGHT BARING STATUS. PATIENT CLAIMED HE COULD NOT MAINTAIN HIS 50% WEIGHT BARING STATUS DUE TO LIVING ALONE. HE HAD A WALKER BUT WAS NOT USING IT. HE HAS A HISTORY OF NON COMPLIANCE POST OP. HE HAD AN ADDITIONAL SURGERY PERFORMED AT ANOTHER FACILITY.

  Patient problems: Failure of Implant

  MAUDE report 15419599 ↗
• InjuryApr 26, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT "A GAMMA NAIL BROKE THIS 01/04 DURING AN INTERVENTION AT THE CH OF CHATEAUROUX." ADDITIONAL INFORMATION RECEIVED: THE NAIL BROKE POST-OPERATIVELY, LIKELY NON-UNION WAS OBSERVED. A REVISION TO TOTAL HIP PROSTHESIS WAS PERFORMED.

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

  MAUDE report 14208292 ↗
• InjuryFeb 18, 2022Break; Fracture; Break; Fracture

  THE HUSBAND OF A PATIENT REPORTED THE FOLLOWING: "I AM REFERRING TO THE PREVIOUS CORRESPONDENCE ((B)(4)) WHICH IN SUMMARY STATED THAT AFTER AN OPERATION, ON MY WIFE'S LEFT FEMUR, SHE HAD BEGUN TO SUFFER FROM ATOPIC DERMATITIS. INTERVENTION ON (B)(6) 2019 PERFORMED AT THE (B)(6) HOSPITAL. SUBSEQUENTLY, THE FACT THAT FROM THE METAL TESTS DONE TO MY WIFE, SHE WAS NOT ALLERGIC TO TITANIUM OR THE MATERIAL OF THE NAIL, FROM A CERTAIN POINT OF VIEW CALMED ME, BUT THEN AFTER A YEAR ((B)(6) 2021) THE NAIL BROKE. FROM ASST (B)(6) HOSPITAL REPORT I READ: "X-RAY: UNCONSOLIDATED EXISTENCE OF PERTROCHANTERIC FRACTURE WITH REVERSE RIM AND FATIGUE FRACTURE OF THE FEMORAL NAIL AT THE LEVEL OF THE CEPHALIC SCREW." THE PATIENT ALSO REPORTED PAIN.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 13560494 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: CUTOUT OF PROXIMAL FEMORAL RESTORATION WITH GAMMA3 U-BLADE, U-BLADE IS BENT, REMOVAL DIFFICULT.

  Patient problems: Hip Fracture

  MAUDE report 12647604 ↗
• MalfunctionAug 31, 2021Fracture; Fracture

  IT WAS REPORTED THE NAIL BROKE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 12390790 ↗
• InjuryJun 15, 2021Fracture; Fracture

  AS REPORTED: "BROKEN GAMMA3 NAIL WHICH REQUIRED REVISION SURGERY."

  Patient problems: Failure of Implant

  MAUDE report 12005331 ↗
• InjuryNov 24, 2020Fracture; Fracture

  THE CUSTOMER REPORTS A BROKEN GAMMA NAIL. THERE WAS SUDDEN PAIN. THE NAIL WAS REMOVED. AN IMPLANTATION OF A HIP ENDOPROSTHESIS WAS PERFORMED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10891065 ↗
• InjuryAug 21, 2020Fracture; Fracture

  THE CUSTOMER REPORTS A BROKEN GAMMA NAIL. REVISION HAD TO BE PERFORMED.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10436523 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: A LEFT-SIDED PERTROCHANTERIC FEMUR FRACTURE OF THE PATIENT WAS TREATED WITH GAMMA-NAIL OSTEOSYNTHESIS ON (B)(6) 2017. THE PATIENT COMPLAINS OF INCREASING PAIN IN THE LEFT HIP WITHOUT HAVING FALLEN BEFORE.

  Patient problems: Implant Pain; Pain

  MAUDE report 10207404 ↗
• InjuryMar 14, 2020Fracture; Fracture

  IT WAS REPORTED, THE NAIL BROKE. THE BROKEN NAIL WAS EXPLANTED ON 13TH FEBRUARY.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9832742 ↗