AXSOS 627648SRecalls & 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 07613327005288), received between Mar 1, 2023 and Jul 2, 2026 — 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Insufficient Information2
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689984 ↗InjuryJul 2, 2026Fracture
IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A REVISION SURGERY.
Patient problems: Insufficient Information
MAUDE report 25689798 ↗InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "USE OF THE PERIPRO SYSTEM ON THIS CASE WAS NOT BECAUSE OF A DEFICIENCY IN PRIOR FIXATION NOR HARDWARE FAILURE WITH THE PREVIOUSLY IMPLANTED T2 ALPHA GT FEMUR AND AXSOS 3 DISTAL FEMUR PLATE. THIS PT WAS BROUGHT TO THE OR WITH AN INFECTION. SO, THE PRESENT DISTAL FEMUR PLATE WAS REMOVED, I & D WAS PERFORMED, AND FEMUR WAS RE-FIXATED WITH THE PERIPRO PLATE COATED IN ANTIBIOTIC CEMENT. "
Patient problems: Unspecified Infection
MAUDE report 18107836 ↗InjuryMar 1, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED THAT DUE TO A PLATE BREAKAGE THE PATIENT WAS REVISED. THE PATIENT HAD A DISTAL FEMUR FRACTURE ON THE SAME LEG AND A NEW PLATE WAS PUT IN. IT WAS MENTIONED THAT THE PATIENT WALKED AROUND WITH THE BROKEN PLATE BEFORE OPTING TO HAVE IT REMOVED. THE PATIENT DID NOT HAVE SURGERY ON (B)(6) 2021, IT WAS JUST DOCUMENTED THAT THE PATIENT SLIPPED AND HAD A BROKEN PLATE.
Patient problems: Failure of Implant
MAUDE report 16458558 ↗
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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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