AXSOS 627610Recalls & 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
- 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 07613252579571), received between Aug 19, 2019 and Dec 1, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture2
Patient problems
- Failure of Implant2
- Injury1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2023Break; Fracture; Break; Fracture
AS REPORTED: "AN AXSOS 3 DISTAL LATERAL FEMUR PLATE WAS IMPLANTED IN THE PATIENT AT THE END OF MARCH 2023 AND FRACTURED IN THE PATIENT IN THE WEEK OF (B)(6) 2023. THE PLATE WAS REMOVED ON (B)(6) 2023 AND A T2 ALPHA FEMUR RETROGRADE NAIL WAS INSERTED."
Patient problems: Failure of Implant
MAUDE report 18247732 ↗InjuryAug 19, 2019Break; Fracture; Fracture
SURGEON REPORTED BROKEN AXSOS PLATE WHICH RESULTED IN REVISION SURGERY.
Patient problems: Failure of Implant; Injury; No Code Available
MAUDE report 8908306 ↗
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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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