Wagner SL Revision® 01.00109.118Recalls & reported problems
Zimmer GmbH · Class 2
All models of Wagner SL Revision (33)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024277847), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2023Fracture; Fracture
UPON REVIEW OF THIS COMPLAINT FROM AN INVESTIGATION PERSPECTIVE, IT IS CONSIDERED THAT THE WAGNER SL REVISION, TRIAL STEM, DISTAL, WITHIN THIS COMPLAINT, DOES NOT IMPACT THE REPORTED EVENT. THE DEVICE INVOLVED IN THE REPORTED EVENT HAS ALREADY BEEN REPORTED. SEE REPORT NUMBER 0009613350 - 2023 - 00208.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16543924 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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