Wagner SL Revision® 01.00109.806Recalls & 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
- 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 00889024277977), received between Dec 17, 2020 and May 4, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture2
- Difficult to Remove1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TRIAL LOCKING SCREW BROKE LEAVING THE DISTAL SEGMENT OF THE STEM IN THE FEMUR. AN ETO (EXTENDED TROCHANTERIC OSTEOTOMY) HAD TO BE PERFORMED TO EXTRACT THE DISTAL SEGMENT OF THE WAGNER SL STEM. PATIENT INVOLVEMENT - MORE COMPLEX SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 14277784 ↗InjuryDec 17, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove
INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11026032 ↗
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- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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