AXSOS 627642Recalls & reported problems
Stryker GmbH · Distal Lateral Femur Plate · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252579670), received between Jan 17, 2017 and Dec 10, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Break2
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Fall1
- Injury1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THERE WAS FRACTURE OF OSTEOSYNTHESIS PLATE IN RIGHT FEMUR THAT REQUIRED REMOVAL AND NAIL INSERTION.
Patient problems: Insufficient Information
MAUDE report 23769155 ↗InjuryNov 22, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6). ON (B)(6) 2023, SHE STUMBLED AT HOME (LOW INERTIA TRAUMA) AND THE FEMORAL PLATE BROKE. SHE HAD TO RETURN TO THE OPERATING THEATRE ON (B)(6) 2023.
Patient problems: Failure of Implant; Fall
MAUDE report 18191851 ↗InjuryMay 19, 2020Fracture; Fracture
PLATE BROKE AFTER IMPLANTATION. REVISION SURGERY OCCURRED AS A RESULT.
Patient problems: Failure of Implant; Injury; Pain
MAUDE report 10073214 ↗InjuryJan 17, 2017Break
REP REPORTED SCHEDULED REVISION SURGERY FOR A BROKEN LEFT LATERAL FEMURAL PLATE ON (B)(6) 2016 DUE TO THE PLATE BREAKING.
Patient problems: Bone Fracture(s)
MAUDE report 6258443 ↗
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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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