AXSOS 627646Recalls & 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
- 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 07613252579694), received between May 8, 2018 and Mar 7, 2023 — classified as 3 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.
Most reported problems
Device problems
- Fracture3
- Break1
Patient problems
- Failure of Implant2
- Hip Fracture1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2023Break; Fracture; Break; Fracture
AS REPORTED: "AXSOS 3 DISTAL FEMUR BROKE IN LESS THAN 2 MONTHS AFTER SURGERY.". THIS RESULTED IN A REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 16494592 ↗InjurySep 9, 2021Fracture; Fracture
AS REPORTED: "REFRACTURE OF MID SHAFT RIGHT FEMORAL #& FRACTURE OF STRYKER AXSOS 3 DISTAL FEMORAL PLATE.
Patient problems: Failure of Implant; Hip Fracture
MAUDE report 12446303 ↗InjuryMay 8, 2018Fracture
AS REPORTED: "PATIENT WAS GETTING INTO SHOWER AND HEARD A POP". PATIENT'S FEMUR WAS REVISED. OPERATIVE SIDE IS RIGHT.
Patient problems: No Code Available
MAUDE report 7497185 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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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