GAMMA 8160-0095SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327511017), received between Dec 19, 2023 and Feb 13, 2026 — classified as 7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANT FAILED. THE DOCTOR DESCRIBED IT AS THE LAG SCREW CAUSED THE NAIL ITSELF TO BEND CAUSING THE NAIL TO BREAK INTO TWO. IT BROKE WHERE THE LAG SCREW SITS IN THE NAIL ITSELF. THE PATIENT UNDERWENT A REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 24333522 ↗
• InjuryNov 4, 2025Migration; Migration

  AS REPORTED: "PATIENT UNDERWENT ORIF (GAMMA 4) FOR A RIGHT FEMORAL TRANSVERSE FRACTURE ABOUT 2 MONTHS AGO. ON (B)(6) 2025, AT POST-OPERATIVE FOLLOW-UP, IT WAS CONFIRMED BY X-RAY THAT THE LAG SCREW HAD BECOME DISLODGED. ON (B)(6) 2025, A REOPERATION WAS PERFORMED. THE DISLODGED LAG SCREW WAS REMOVED, REPLACED WITH ARTIFICIAL BONE, AND A NEW LAG SCREW WAS INSERTED."

  Patient problems: Joint Dislocation

  MAUDE report 23465221 ↗
• InjuryJun 20, 2025Migration; Migration

  SUBJECT: (B)(6) STRYKER PEGASUS STUDY. MIGRATION PIN MIGRATED THROUGH BONE INTO MUSCLE RELATIONSHIP TO DEVICE: DEFINITELY RELATED, RELATIONSHIP TO PROCEDURE: DEFINITELY RELATED.

  Patient problems: Insufficient Information

  MAUDE report 22297715 ↗
• InjuryNov 14, 2024Migration; Migration

  AS REPORTED: "SUBJECT: (B)(6) STUDY. PROMINENT LAG SCREW CAUSING PAIN. PATIENT CAME TO CLINIC DUE TO PAIN IN RIGHT LATERAL THIGH THAT HAS NOT RESPONDED TO CONSERVATIVE MANAGEMENT. X-RAY SHOWED PROMINENT LAG SCREW LIKELY CAUSING SIGNIFICANT DISCOMFORT WITH WALKING. PATIENT TIRED ANTI-INFLAMMATORY MEDICATION, PHYSICAL THERAPY, THEN CAME TO CLINIC AND RECEIVED AN X-RAY. SURGERY IS ANTICIPATED TO EXCHANGE THE SYMPTOMATIC LAG SCREW. THIS IS UNANTICIPATED. THE SET SCREW WAS FULLY LOCKED AND THERE WAS STILL SIGNIFICANT MIGRATION OF THE LAG SCREW POST-OP."

  Patient problems: Implant Pain

  MAUDE report 20682078 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) POST MARKET CLINICAL EVALUATION OF GAMMA 4: PROSPECTIVE, MULTICENTER, FOLLOW-UP STUDY (PEGASUS). DEEP VEIN THROMBOSIS. PATIENT NOTICED ACUTE WORSENING OF LEFT LEG SWELLING ON 02 JUN 2024. HE REPORTED TO SURGEON WHO RECOMMENDED DVT STUDY. US AT ED ON (B)(6) SHOWED DVT OF LEFT PERONEAL VEIN. PCP PRESCRIBED ELOQUIS FOR AT LEAST 3-MONTH COURSE. STILL TAKING AS OF 30 SEP 2024."

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20630036 ↗
• InjuryJul 26, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO MEDIAL MIGRATION OF THE LAG SCREW. THE LAG SCREW WAS NOT ENGAGED. IT WAS NOT FULLY SET OR CENTERED IN THE GROOVE. THE SURGEON REVISED WITH A SHORTER RC. THERE WAS MINIMAL PURCHASE IN THE HEAD

  Patient problems: Perforation

  MAUDE report 19844917 ↗
• InjuryDec 19, 2023Migration; Migration

  IT WAS REPORTED THAT THE SURGEON IMPLANTED A GAMMA4 INTERMEDIATE NAIL IN COMBINATION WITH AN RC LAG SCREW AND WITH USE OF THE ANTI-ROTATION CLIP FOR TREATMENT OF AN UNSTABLE FRACTURE IN THE TROCHANTERIC REGION. HE TOOK OUT THE SHORT NAIL AND PUT IN A LONGER NAIL. FOLLOWING INFORMATION WAS RECEIVED FROM THE SALES REP: "THE PREVIOUS NAIL WAS A STRYKER GAMMA4 NAIL THAT WAS INCORRECTLY POSITIONED AND CUT-OUT. THE SURGEON ELECTED TO REVISE IT AND ADDED A LONGER NAIL."

  Patient problems: Perforation

  MAUDE report 18353935 ↗