Wagner SL Revision® 01.00109.808Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024277991), received between Oct 3, 2019 and Jun 10, 2024 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Mechanical Jam1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2024Fracture; Naturally Worn; Fracture; Naturally Worn
IT WAS REPORTED THAT UPON SETTING INSTRUMENTS UP FOR A SURGERY, THE PRODUCT WAS WORN AND BROKEN. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19497092 ↗MalfunctionDec 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DURING REVISION SURGERY, THE WAGNER SL REVISION, IMPACTOR FOR STEM WAS DAMAGED ON THE THREADS.
Patient problems: No Information
MAUDE report 9436630 ↗MalfunctionOct 3, 2019Mechanical Jam; Mechanical Jam
NO CHANGE TO PREVIOUSLY REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9150959 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
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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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