GAMMA 8525-0380SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327477627), received between Jun 21, 2023 and Feb 12, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Positioning Failure; Malposition of Device

  AS REPORTED: "DUE TO INSUFFICIENT ADJUSTMENT OF THE ADJUSTING DEVICE, THE MOST DISTAL ADVANCE LOCKING SCREW OF THE TWO DISTAL TRANSVERSE STOPS WAS INSERTED INTO THE BONE WITHOUT PASSING THROUGH THE NAIL. THIS WAS DISCOVERED AFTER WOUND CLOSURE. REINSERTION OF THE SCREW OUTSIDE THE NAIL WAS NOT PERFORMED, AND THE PLAN IS TO OBSERVE THE SITUATION AND TAKE ACTION AS APPROPRIATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328420 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS. SUBJECT: (B)(6). ONSET DATE: (B)(6) 2025 - PAIN. PATIENT FIRST LEFT MESSAGE WITH INTERNAL MEDICINE ABOUT PAINFUL LEFT HIP ON (B)(6) 2025. SHE WAS SEEN BY THE SURGEON ON (B)(6) 2025. SHE DESCRIBED DIFFUSE LEFT HIP PAIN RADIATING DOWN LEG AND WORSENED BY WEIGHTBEARING. ASSESSMENT AT (B)(6) 2025 FOLLOW-UP INCLUDED GT BURSITIS, ARTHRITIS, AND LEFT SI JOINT PAIN. SHE HAS TRIED GABAPENTIN AND GOT CORTISONE INJECTION AT THIS FOLLOW-UP. SHE IS CONSIDERING HIP REPLACEMENT SURGERY."

  Patient problems: Arthritis; Bursitis; Implant Pain

  MAUDE report 21806087 ↗
• InjuryApr 18, 2024Break; Fracture; Device Damaged by Another Device; Break; Fracture; Device Damaged by Another Device

  IT WAS REPORTED: "PATIENT WAS WALKING UP STEPS DURING ASSIGNED PHYSICAL THERAPY AND HEARD A POP." PATIENT PRESENTED WITH A BROKEN NAIL WHICH REQUIRED A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 19139648 ↗
• InjurySep 8, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY ON A GAMMA 4 NAIL ON WAS PERFORMED A FEW MONTHS AFTER THE INITIAL SURGERY. THE NAIL BROKE RIGHT AT THE LAG SCREW INTERFACE.

  Patient problems: Failure of Implant

  MAUDE report 17712463 ↗
• InjuryJun 21, 2023Malposition of Device; Malposition of Device

  AS REPORTED: "IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THE LAG SCREW PENETRATING THROUGH THE PATIENT'S FEMORAL HEAD. THE NAIL AND ALL SCREWS WERE REMOVED AND A HEMI HIP WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON."

  Patient problems: Hip Fracture; Perforation

  MAUDE report 17172155 ↗