GAMMA 3066-0095SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540595997), received between Nov 15, 2018 and Oct 16, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "OVER-TELESCOPING OF THE LAG SCREW DUE TO NON-UNION. THE SCREW DOES NOT HAVE A CUTOUT. THE LAG SCREW PROTRUDED TO LATERAL DUE TO COLLAPSE OF THE FEMORAL NECK. THE PATIENT REQUIRED A REVISION SURGERY."

  Patient problems: Perforation

  MAUDE report 23318451 ↗
• 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 22287630 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY SURGERY WITH GAMMA3 NAIL AND U-LAG SCREW WAS PERFORMED ON (B)(6) 2022. ON (B)(6) 2025, WHEN THE PATIENT VISITED THE HOSPITAL WITH AN IRREGULAR HEARTBEAT, LAG SCREW CUT-OUT WAS OBSERVED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED FOR REMOVING U-LAG SCREW."

  Patient problems: Perforation

  MAUDE report 21762669 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FROM A TROCHANTERIC NAIL GAMMA4 NAIL TO A TOTAL HIP DUE TO THE ROTATION OF LAG SCREW NO T BEING MAINTAINED.

  Patient problems: Insufficient Information

  MAUDE report 20092081 ↗
• InjuryMay 7, 2022Migration; Migration

  AS REPORTED: "GAMMA3 PRIMARY SURGERY WAS PERFORMED ON FEBRUARY 18, 2022 WITHOUT ANY PROBLEM. APPROXIMATELY TWO MONTHS POSTOPERATIVELY, THE U-LUG SCREW PENETRATED THE FEMORAL HEAD. REVISION SURGERY WITH BIPOLAR WAS PERFORMED ON (B)(6) 2022."

  Patient problems: Insufficient Information

  MAUDE report 14318034 ↗
• InjuryOct 5, 2021Material Deformation; Migration; Material Deformation; Migration

  ON (B)(6) 2021, GAMMA 3 SURGERY WAS PERFORMED ON THE RIGHT PROXIMAL FEMUR. ON (B)(6) 2021, ALTHOUGH THE DETAILS OF THE BREAKAGE ARE UNKNOWN, THE U-BLADE LAG SCREW THAT WAS FIXED TO THE GAMMA 3 NAIL WAS FOUND TO HAVE FAILED AND MOVED UPWARD TO THE HEAD OF THE BONE. THE U-LAG PORTION OF THIS LAG SCREW WAS DEFORMED SO THAT IT OPENED FORWARD. THE SURGEON PLANS TO COLLECT THE DEFECTIVE DEVICE WHEN PERFORMING THE GIRDLE STONE LATER.

  Patient problems: Failure of Implant

  MAUDE report 12579446 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED: "AFTER THA SURGERY (RIGHT SIDE), CUTOUT OF A LAG SCREW OCCURRED AT THE FEMORAL HEAD. AFTER THAT, THE LAG SCREW INVADED THE PELVIS. THE INITIAL SURGERY PERFORMED ON (B)(6) 2021, THE EVENT WAS CONFIRMED ON (B)(6) 2021. THE RE-OPERATION WAS PERFORMED ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED ON 17-FEB-202: "AT THE TIME OF THE INITIAL OPERATION, THE OPERATION WAS COMPLETED WITHOUT INSERTING THE U BLADE OF THE U LAG SCREW AND THE END CAP FOR THE LAG SCREW. IN ADDITION, IT HAS BEEN CONFIRMED THAT THE LAG SCREW DID NOT TURN WHEN THE SET SCREW WAS NOT LOOSENED IN THE REMOVAL PROCESS. SO, THE SURGEON RECOGNIZED THAT THE SET SCREW WAS FIXED TO SOME EXTENT."

  Patient problems: Hip Fracture; Perforation

  MAUDE report 11417551 ↗
• InjuryApr 4, 2019Appropriate Device Problem Term/Code Not Available; Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GAMMA3 U-LAG SCREW SURGERY ON (B)(6) 2019. AFTER THE SURGERY, THE CUTOUT OF U-LAG SCREW AND THE BENDING OF U-BLADE WERE CONFIRMED. THEN GAMMA3 EXTRACTION AND REVISION TO THA WAS PERFORMED ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8482949 ↗
• InjuryNov 15, 2018Migration

  CUT OUT OF U LAG SCREW OCCURS. PATIENT FELT PAIN ON HIS HIP FOR SEVERAL WEEKS AND DIFFICULT TO WALK. THEN, WHEN FALLING ON 18TH, VISITED IN THE HOSPITAL AND AN X - RAY FILM WAS TAKEN, IT TURNED OUT THAT THE LAG SCREW HAD CUT OUT AND REACHED THE ACETABULAR. THERE IS NO DISLOCATION OF THE PIECES OF THE BONY SKULL, AND ONLY THE LAG SCREW HAS CUT OUT. AS A MEASURE AFTER OCCURRENCE, ON 12TH OCTOBER REPLACED 120 ° GAMMA NAIL.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Fall; Pain

  MAUDE report 8074990 ↗