GAMMA 8160-0085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327510959), received between Oct 16, 2023 and May 9, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). STRYKER PEGASUS STUDY. DEEP VEIN THROMBOSIS. ACUTE DVT (LEFT PERONEAL VEIN) DIAGNOSED AT EMERGENCY DEPARTMENT ON (B)(6) 2023 AFTER A FEW DAYS OF WORSENING LEG SWELLING AND PAIN. DIAGNOSIS VIA ULTRASOUND. PATIENT MEDICATION CHANGED FROM HEPARIN TO ELIQUIS AND DISCHARGED SAME DAY. BY ORTHOPEDIC F/U ON (B)(6) 2023 PATIENT WAS SYMPTOM-FREE."

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 21993356 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS SUBJECT: (B)(6). HYPERKALEMIA/ACUTE RENAL FAILURE WITH ELEVATED LIVER ENZYMES, CAUSING UREMIA AND ENCEPHALOPATHY. PATIENT RETURNED TO HOSPITAL APPROXIMATELY ONE MONTH AFTER ORTHOPAEDIC REOPERATION WITH ACUTE RENAL FAILURE PRESENTING WITH CONFUSION, POSSIBLY DUE TO COMBINATION OF REOPERATION/ANTIBIOTICS AND UNDERLYING COMORBIDITIES (METASTATIC CANCER)."

  Patient problems: Renal Impairment

  MAUDE report 20854321 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: STRYKER PEGASUS SUBJECT: (B)(6(. PATIENT ADMITTED TO HOSPITAL ON (B)(6) 2024 AND SEEN BY ORTHOPEDICS FOR 3 CM AREA OF DEHISCENCE OF SUPEROLATERAL ASPECT OF RIGHT KNEE. THIS WAS IRRIGATED AND CLOSED BEDSIDE WITH NYLON SUTURES AND LATER WRAPPED WITH COMPRESSION DRESSING, THEN SOFT."

  Patient problems: Wound Dehiscence

  MAUDE report 20854287 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: STUDY: STRYKER PEGASUS SUBJECT: (B)(6). X-RAYS TAKEN ON (B)(6) 2024 SHOW ANTERIOR DISPLACEMENT OF THE DISTAL FEMORAL ROD WITH SUGGESTS PROXIMAL OSSEOUS COLLAPSE DUE TO TUMOR BURDEN. OPEN REDUCTION INTERNAL FIXATION WITH LATERAL PLATE AND SCREWS OVERLAPPING THE GAMMA 4 IMPLANT."

  Patient problems: Bone Fracture(s)

  MAUDE report 20543327 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: CLINICAL STUDY PEGASUS SUBJECT (B)(6). ADVERSE EVENT: PAIN PATIENT EXPERIENCING SYMPTOMS OF GREATER TROCHANTERIC BURSITIS, POSSIBLY FROM HER PROMINENT LAG SCREW ON THE LATERAL BORDER OF THE FEMUR FOLLOWING FX COMPRESSION PATIENT PREVIOUSLY ACHIEVED BONE CONSOLIDATION AT 3 MONTH VISIT ((B)(6) 2023) BOTH CLINICALLY AND RADIOGRAPHICALLY.

  Patient problems: Bursitis; Implant Pain

  MAUDE report 18790255 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PEGASUS SUBJECT (B)(6). XRAY SHOW HARDWARE MIGRATION/CUT-OUT HARDWARE WAS REMOVED (B)(6) 2023. UPDATE 01/23/2024 - NONUNION, LEFT INTERTROCHANTERIC FRACTURE. CUT OUT OF GAMMA NAIL, LEFT HIP WITH HARDWARE PAIN.

  Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture; Perforation

  MAUDE report 18563160 ↗
• 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: 23.JUN.2023.

  Patient problems: Implant Pain

  MAUDE report 18326966 ↗
• InjuryOct 16, 2023Migration; Migration

  AS REPORTED: "GAMMA 4 LONG NAIL WAS IMPLANTED, BUT THE LAG SCREW MIGRATED POSTOPERATIVELY AND THE FRACTURE REDUCTION COLLAPSED. REVISION SURGERY IS SCHEDULED ON (B)(6) 2023."

  Patient problems: Failure of Implant

  MAUDE report 17939475 ↗