GAMMA 8525-1400SRecalls & reported problems
Stryker GmbH · Long Nail, LEFT · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327474824), received between Nov 24, 2025 and Mar 4, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Device Damaged by Another Device1
Patient problems
- Fall1
- Insufficient Information1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2026Fracture; Device Damaged by Another Device
IT WAS REPORTED THAT A BROKEN GAMMA 4 NAIL HAS BEEN EXPLANTED IN (B)(6) AREA HOSPITAL, (B)(6).
Patient problems: Insufficient Information
MAUDE report 24508105 ↗InjuryNov 24, 2025Fracture; Fracture
REPORTED BY REP: "NEW PER FOR A BROKEN GAMMA 4 NAIL. PATIENT AGE: 79 GENDER: FEMALE MEDICAL CONCERNS: ATYPICAL FRACTURE, HIGH RISK FOR IMPLANT FAILURE DATE OF IMPLANTATION: (B)(6) 2025. IMPLANT DETAILS: 11X400MM (125) LEFT GAMMA4 NAIL. IMPLANT ID: 8525-1400. LOT NUMBER: K1A4934 3 MONTHS POST-OP FROM IMPLANTATION: PATIENT CAME IN FOR REVIEW; X-RAYS SHOWS SIGNS OF NON-UNION AND PATIENT TOLD THEY ARE HIGH RISK OF IMPLANT FAILURE. DATE OF IMPLANT BREAKAGE: EXACT DATE UNKNOWN BUT BREAKAGE IDENTIFIES ON (B)(6) 2025. IMMEDIATE EVENTS PRIOR TO IMPLANT BREAKAGE: (B)(6) 2025 FALL, ON (B)(6) 2025: INCREASED HIP PAIN, (B)(6) 2025: PRESENTED TO A+E WHERE LEG GAVE WAY + X-RAYS TAKEN TO IDENTIFY BROKEN IMPLANT. DATE OF REVISION: (B)(6) 2025 - IMPLANT REMOVED AND ENHANCED FOR PROXIMAL FEMORAL PLATE. WAS THE PATIENT ADVERSELY AFFECTED? YES, PATIENT REQUIRED A REVISION PROCEDURE CONSISTING OF REMOVAL OF GAMMA4 NAIL AND INSERTION OF PROXIMAL FEMORAL PLATE ON (B)(6) 2025."
Patient problems: Fall; Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 23632755 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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