GAMMA 3125-0170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540375063), received between Sep 10, 2015 and Oct 29, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE PATIENT VISITED THE CLINIC COMPLAINING OF PAIN, AND THE NAIL WAS REMOVED DUE TO NECROSIS."

  Patient problems: Necrosis; Pain

  MAUDE report 23413656 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PERIPROSTHETIC FRACTURE WAS CONFIRMED NEAR THE GAMMA3 NAIL. THE INITIAL SURGERY DATE WAS UNKNOWN AS IT WAS PERFORMED ANOTHER HOSPITAL AND THERE WAS NO DATA CONFIRMED WHILE OVER 10 YEARS HAS BEEN PAST FROM THE INITIAL SURGERY."

  Patient problems: Limb Fracture

  MAUDE report 22496738 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: PRIMARY G3 SURGERY WAS PERFORMED ON (B)(6) 2015. THE PATIENT FELL AND RE-FRACTURED THE BONE AT UNDER THE U-LAG SCREW OF G3. REVISION SURGERY FOR REMOVING G3 AND REPLACING LONG NAIL WAS PERFORMED ON (B)(6) 2025. DURING SURGERY, THE TIP OF THE T-HANDLE BECAME BENT DUE TO THE HARDNESS OF THE BONE DURING REMOVAL. THIS RECORD COVERS THE REVISION SURGERY."

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22287629 ↗
• InjuryNov 19, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED; "ON (B)(6) 2024, PRIMARY GAMMA 3 SURGERY FOR A PATIENT WITH RIGHT FEMORAL TROCHANTERIC FRACTURE WAS PERFORMED. ON (B)(6) 2024, NAIL FRACTURE DUE TO PSEUDARTHROSIS WAS CONFIRMED. REVISION SURGERY TO REPLACE THE NAIL WITH GAMMA 4 LONG NAIL WILL BE PERFORMED ON (B)(6) 2024".

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

  MAUDE report 20719162 ↗
• InjuryJul 3, 2024Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A BROKEN GAMMA3 NAIL AND REQUIRED REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 19671172 ↗
• InjuryMay 21, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "NAIL BROKEN OFF AT LAG SCREW HOLE. REVISION SURGERY IS PLANNED TO PERFORM ON 30 APRIL."

  Patient problems: Failure of Implant

  MAUDE report 19364770 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A PATIENT WHO UNDERWENT SURGERY WITH A GAMMA3 U-LAG SCREW ON (B)(6) 2018, FELL WHILE TRANSFERRING FROM A PORTABLE TOILET AT HOME ON (B)(6) 2022. SUBSEQUENTLY, IT WAS DISCOVERED THAT SHE HAD A FEMORAL NECK FRACTURE ON LEFT SIDE, SO ON (B)(6) 2022, SHE UNDERWENT SURGERY TO REMOVE GAMMA 3 AND REPLACED IT WITH A BIPOLAR."

  Patient problems: Hip Fracture

  MAUDE report 16133828 ↗
• MalfunctionMar 12, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED; "THE TARGET DEVICE AND THE HOLDING SCREW WERE STUCK AND COULD NOT BE REMOVED FROM THE NAIL AFTER THE NAIL INSERTION. AFTER THAT, OTHER INSTRUMENTS AND NAIL WERE USED AND THE SURGERY WAS FINISHED." TIME EXTENSION OF ABOUT 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743544 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO INFECTION. A SHORT GAMMA FEMORAL NAIL, LAG SCREW, TOP LOCKING SCREW, AND DISTAL SCREW WERE REVISED TO A CEMENTED TOTAL HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13282909 ↗
• InjuryJul 30, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "DURING LAG SCREW DID NOT SLIDE, AND IT PENETRATED THE FEMORAL HEAD. THE SURGEON IT COULD BE DUE TO THE SET SCREW."

  Patient problems: Failure of Implant; Perforation

  MAUDE report 10348098 ↗
• InjuryJun 10, 2020Fracture; Fracture

  AS REPORTED: FIRST SURGERY IN (B)(6) 2019. THE PATIENT SUDDENLY FELT PAIN, SO THE PATIENT VISITED THE CLINIC ON (B)(6). IMAGE DIAGNOSIS REVEALED FRACTURE OF THE NAIL DUE TO FALSE JOINT. (B)(6): RE-OPERATED TO CHANGE TO LONG NAILS. UPON REMOVAL, THE NAIL WAS PARTIALLY BROKEN IN FRONT OF THE LAG SCREW HOLE.

  Patient problems: Injury

  MAUDE report 10139598 ↗
• InjuryFeb 18, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED, GAMMA 3 PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018. AFTER THE SURGERY THE NAIL BREAKAGE WAS CONFIRMED. CUSTOMER / SALES REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 9721503 ↗
• InjuryJun 25, 2019Device Dislodged or Dislocated

  GAMMA3 PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2014. THIS TIME CUTOUT OF THE LAG SCREW WAS FOUND. IT IS UNKNOWN WHEN THE CUTOUT OCCURRED. THE PATIENT HAS FELT PAIN BUT IS ABLE TO WALK. REVISION SURGERY TO THA WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8732816 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem

  IT'S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT HIP INTRAMEDULLARY NAIL FIXATION OF INTERTROCHANTERIC FRACTURE ON (B)(6) 2018 IN WHICH A STRYKER GAMMA 3 NAIL WAS USED. IT IS FURTHER ALLEGED THAT THE HIP FAILED AND CAUSED THE PATIENT TO SUSTAIN A SUBSEQUENT FRACTURE IN HER HIP, FORCING HER TO UNDERGO REVISION SURGERY IN (B)(6) OF 2019.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 8716497 ↗
• InjuryMay 22, 2019Collapse; Material Protrusion/Extrusion

  REP REPORTED THAT THE SURGEON REVISED A GAMMA NAIL TO A REST MOD THA WITH MDM. THE PATIENT RECEIVED THE GAMMA NAIL ABOUT 2 YEARS AGO FOR A FEMORAL FRACTURE, THEN DEVELOPED AVASCULAR NECROSIS. SUBSEQUENT COLLAPSE OF THE FEMORAL HEAD HAS RESULTED IN THE LAG SCREW PROTRUDING INTO THE JOINT SPACE REQUIRING REVISION.

  Patient problems: Necrosis

  MAUDE report 8631624 ↗
• InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING UNKNOWN DATE, AN UNKNOWN GAMMA3 SHORT NAIL WAS IMPLANTED FOR MULTIPLE INJURY OF FRACTURE OF A CLAVICLE AND THE FEMORAL NECK FRACTURE. ON (B)(6) 2016, SURGICAL TREATMENT AGAIN PATIENT WAS REVISED TO GAMMA3 LONG DUE TO NONUNION OF THE FEMORAL NECK FRACTURE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6404870 ↗
• InjuryNov 29, 2016Failure To Adhere Or Bond

  ON (B)(6) 2015, THE PATIENT UNDERWENT THE SURGERY WITH THE G3 NAIL AND U-LAG SCREW. AFTER SURGERY, THE PATIENT FELT THE PAIN. THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE FRACTURE PART WAS NON-UNION. THEREFORE, THE PATIENT UNDERWENT THE REVISION SURGERY BY THE BONE GRAFT AND THE DISTAL SCREW REMOVE ON (B)(6) 2016.

  Patient problems: Pain

  MAUDE report 6133810 ↗
• InjurySep 10, 2015Fracture

  THE PATIENT WAS INJURED IN CAR ACCIDENT IN (B)(6) 2015. TROCHANTERIC FRACTURES WAS OCCURRED. ON (B)(6), GAMMA3 WAS USED FOR OSTHEOSYNTHESIS. IN (B)(6) 2015, THERE IS NO PROBLEM. IN (B)(6) 2015, HE PATIENT FELT SOMETHING WRONG AND ADMITTED HIMSELF TO HOSPITAL. THE PATIENT SAID THAT HE BECAME LESS ABLE TO WALK SUDDENLY AND NAIL FRACTURE WAS CONFIRMED THOUGH HE WAS NOT INJURED AND DID NOT FELL AFTER THE OP. GAMMA3 WAS REMOVED AND BHA WAS PERFORMED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 5068992 ↗