Wagner Cone Prosthesis® 01.00561.314 (UDI 00889024480797)Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Wagner Cone Prosthesis (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024480797), received between Dec 17, 2018 and Nov 6, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Fracture1
- Loose or Intermittent Connection1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED WHEN IT CAME TIME TO OPEN THE FINAL STEM, AN UNEXPECTED PROBLEM WAS ENCOUNTERED: THE BOX WAS PERFECTLY INTACT, BUT OPENING THE STERILE PACKAGE, THE STEM HAD PUNCTURED THE SECOND PACKAGE. AFTER CAREFUL ANALYSIS, STERILITY SEEMED COMPROMISED, AND THEREFORE THE STEM WAS NOT USED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490424 ↗MalfunctionNov 26, 2021Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated
InjuryDec 17, 2018Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available
PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO BROKEN IMPLANT AND PAIN.
Patient problems: No Information; Pain
MAUDE report 8168375 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- 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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