Wagner SL Revision® 01.00102.215 (UDI 00889024485198)Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024485198), received between Feb 19, 2019 and May 29, 2025 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Integrity Problem1
- Migration1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant2
- No Information2
- Ambulation or Postural Difficulties1
- Aseptic loosening1
- Bone Fracture(s)1
- Implant Pain1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL HIP SURGERY, SUBSEQUENTLY UNDERWENT A REVISION DUE TO UNKNOWN REASON AND AFTER THIS, THE PATIENT WAS REVISED AGAIN, APPROXIMATELY 6 YEARS LATER, DUE TO ASEPTICALLY LOOSE AND BROKEN FEMORAL COMPONENT. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Pain
MAUDE report 22108066 ↗InjuryJul 2, 2020Fracture; Material Integrity Problem; Patient Device Interaction Problem; Fracture; Material Integrity Problem; Patient Device Interaction Problem
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO BONE FRACTURE AND IMPLANT FRACTURE.
Patient problems: Bone Fracture(s); Failure of Implant; Implant Pain
MAUDE report 10223701 ↗InjuryMay 28, 2019Migration; Migration
InjuryFeb 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASON. NOTE: AT THE MOMENT IT IS UNKNOWN WHETHER OR WHAT TYPE OF DEVICE HAVE BEEN EXPLANTED DURING THIS REVISION SURGERY. INFORMATION HAS BEEN REQUESTED.
Patient problems: No Information
MAUDE report 8349665 ↗
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- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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