Wagner SL Revision® 01.00109.116Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024277823), received between Apr 25, 2019 and Jun 19, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
- Difficult to Remove1
Patient problems
- No Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Limb Fracture1
- Tissue Damage1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 17152012 ↗InjuryJan 28, 2021Fracture; Difficult to Remove; Fracture; Difficult to Remove
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Limb Fracture
MAUDE report 11242718 ↗InjuryAug 19, 2019Fracture; Fracture
InjuryAug 19, 2019Fracture; Fracture
InjuryApr 25, 2019Fracture; Fracture
IT WAS REPORTED THAT WHEN SURGEON TRIED TO REMOVE THE STEM TRIAL AFTER FINISHING TRIAL-REDUCTION, THE SCREW BROKE INSIDE THE DISTAL TRIAL, AND MADE IT IMPOSSIBLE TO RETRIEVE THE DISTAL TRIAL FROM THE CANAL. AN OSTEOTOMY HAD TO BE PERFORMED TO TAKE OUT THE INSTRUMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Tissue Damage
MAUDE report 8548245 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
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- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- 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
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
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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