GAMMA 8160-0080SRecalls & reported problems
Stryker GmbH · Lag Screw · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327511079), received between Dec 5, 2024 and Jun 23, 2026 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Migration1
Patient problems
- Bursitis1
- Implant Pain1
- Nonunion/Delayed-union Bone Fracture1
- Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2026Migration
IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO THE LAG SCREW OF THE GAMMA NAIL MIGRATING MEDIALLY INTO THE PATIENT'S ACETABULUM. REP CONFIRMED NO TRAUMA WAS REPORTED TO HIM. THE NAIL AND SCREWS WERE REMOVED, AND THE PATIENT WAS CONVERTED TO A THA USING A RESTORATION MODULAR STEM CONSTRUCT, TRIDENT II SHELL WITH SCREWS, AND AN ADM/ MDM LINER CONSTRUCT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Perforation
MAUDE report 25595824 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT: 002-042. STRYKER PEGASUS STUDY. (B)(6) 2025. NON-UNION (NO BONE CONSOLIDATION WITHIN 6MONTHS). XRAYS TAKEN ON (B)(6) 2025 SHOW THAT BONE IS NOT HEALED. FOLLOW-UP BLOOD TESTS AND CT SCAN ORDERED. PLAN FOR PATIENT TO RETURN TO CLINIC IN THREE WEEKS.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22327155 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "STUDY: (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 20854158 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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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