GAMMA 8120-1170SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327479126), received between Dec 14, 2023 and Dec 5, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS SITE: 002 --- INOVA HEALTH CARE SERVICES SUBJECT: (B)(6). PATIENT SCHEDULED VISIT WITH NON-STUDY ORTHOPEDIST ON (B)(6) 2024 TO ADDRESS LEFT HIP PAIN. PHYSICIAN EXAM ON (B)(6) 2024 NOTED POSSIBLE BURSITIS THAT WAS TREATED WITH A CORTICOSTEROID INJECTION. FOLLOW-UP VISIT NOTE ON (B)(6) 2024 NOTES GOOD RESULTS."

  Patient problems: Bursitis; Implant Pain

  MAUDE report 20855219 ↗
• InjuryNov 14, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "SUBJECT: (B)(6) STRYKER PEGASUS 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 20682000 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING POST MARKET CLINICAL EVALUATION OF GAMMA 4: PROSPECTIVE, MULTICENTER, FOLLOW-UP STUDY, THE FOLLOWING WAS REPORTED: ¿PATIENT WAS 7 DAYS POST OP RIGHT HIP GAMMA NAIL, PRESENTED TO THE ED WITH AN INCREASE IN PAIN/PRESSURE DISTAL TO THE HIP INCISIONS. MEDICAL IMAGING DID NOT REVEAL ANY FINDINGS INDICATING MEDICAL DEVICE ISSUES.¿ ACTION(S) TAKEN: MEDICATION (TRAMADOL, TYLENOL) RESOLVED WITHOUT SEQUELAE: (B)(6) 2023.

  Patient problems: Implant Pain

  MAUDE report 18326952 ↗