Wagner SL Revision® 01.00101.920Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
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 00889024593527), received between Aug 18, 2023 and Aug 18, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
Patient problems
- Bone Fracture(s)1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT HIP TOTAL HIP ARTHROPLASTY TWENTY-EIGHT DAYS AGO. THE PATIENT HAD ALREADY CONFIRMED THE USE OF FORTY-SIX MM ACETABULAR CUP AND THE CORRESPONDING LINER, HOWEVER DURING IMPLANTATION THE SURGEON FOUND THAT THE LINER COULD NOT BE MATCHED TO THE OUTER CUP SIZE AND THE LINER COULD NOT BE STRUCK INTO PLACE AFTER A FEW TRIES, AND BY THIS TIME, THE PATIENT HAD ALREADY SUFFERED FROM A BONE FRACTURE. AFTER REMOVING THE OUTER CUP, IT WAS NECESSARY TO USE A PERCUSSION DISK TO STRIKE THE OUTER CUP OUTSIDE THE PATIENT'S BODY, AND THE SHALLOW THREADS ON THE HEAD OF THE OUTER CUP CONNECTING ROD COULD NOT BE MATCHED WITH THE PERCUSSION DISK. IMMEDIATELY AFTER IMPLANTING THE CUP AGAIN WITH A FORTY-EIGHT MM OUTER CUP, THE BOTTOM OF THE ACETABULUM WAS PIERCED DURING LINER STRIKING, AND THE CUP WAS UNSTABLE, SO THE ACETABULAR CUP SIZE WAS ENLARGED WITH A FIFTY-SIX MM OUTER CUP BEFORE IT WAS PLACED SECURELY, AND A 190/20 STEM WAS USED TO EXPAND THE FEMORAL SIDE OF THE ACETABULUM, WHICH WAS ALSO SMALL. SURGEON USED A CEMENTED FILLER AND PLACED THE 190/20 STEM, HOWEVER DUE TO THE HEIGHT PROBLEM, THE BOTTOM OF THE ACETABULUM AND THE ACETABULAR RIM WERE DAMAGED
Patient problems: Bone Fracture(s); Hemorrhage/Blood Loss/Bleeding
MAUDE report 17570388 ↗
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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