GAMMA 3066-0085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540595973), received between Nov 29, 2016 and May 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 18, 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.

• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "THE LAG SCREW TIP PERFORATED THROUGH THE FEMORAL HEAD CAUSING PAIN FOR THE CONSUMER. A REVISION SURGERY WAS PERFORMED".

  Patient problems: Implant Pain; Perforation

  MAUDE report 19281748 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIF WAS PERFORMED FOR LEFT INTERTROCHANTERIC FEMORAL FRACTURE OF A 88 YEARS OLD FEMALE PATIENT ON (B)(6) 2024. THE X-RAY IMAGE TAKEN ONE MONTH POSTOPERATIVE FOLLOW-UP REVEALED A METAL FRAGMENT LIKE OBJECT THAT WAS NOT SEEN IMMEDIATELY AFTER THE SURGERY WHILE THE PATIENT HAS NO COMPLAINT. THE DOCTOR PROVIDED THE X-RAY IMAGES AND REQUESTS STRYKER TO IDENTIFY IF IT WAS AN IMPLANT PART.

  Patient problems: Foreign Body In Patient

  MAUDE report 18948224 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AA REPORTED: "MY PHYSICIAN DISCOVERED WITH X RAYS THAT YOUR HARDWARE FAILED THAT WAS SURGICAL IMPLANTED IN MY RIGHT LEG ON (B)(6) 2019. ON (B)(6) 2020, A TRAUMA SURGEON REMOVED THE DEFECTIVE HARDWARE FROM MY LEG AT (B)(6) HOSPITAL IN (B)(6). AS A RESULT, SHE HAS MISSED 8 MONTHS FROM WORK, AND SHE WILL PROBABLY MISS 2 MORE MONTHS FOR PHYSICAL THERAPY."

  Patient problems: Failure of Implant

  MAUDE report 10924992 ↗
• InjuryMay 22, 2019Fracture; 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 8631347 ↗
• 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 6133809 ↗