Wagner Cone ProsthesisRecalls & reported problems across all models
Zimmer GmbH · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 16 models of Wagner Cone Prosthesis by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2018 and Jan 22, 2026 — classified as 16 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Wagner Cone Prosthesis problems
Device problems
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem4
- Fracture4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Positioning Problem3
- Patient Device Interaction Problem2
- Use of Device Problem2
- Biocompatibility1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions5
- Pain5
- Aseptic loosening2
- Bone Fracture(s)2
- Failure of Implant2
- Unspecified Infection2
- Bacterial Infection1
Wagner Cone Prosthesis models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Wagner Cone Prosthesis® 01.00561.314Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- Wagner Cone Prosthesis® 01.00561.220Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- Wagner Cone Prosthesis® 01.00569.001Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Wagner Cone Prosthesis® 01.00561.216Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Wagner Cone Prosthesis® 01.00561.217Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- Wagner Cone Prosthesis® 01.00569.116Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner Cone Prosthesis® 01.00569.216Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner Cone Prosthesis® 01.00561.213PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Wagner Cone Prosthesis® 01.00561.214Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 report
- Wagner Cone Prosthesis® 01.00561.216Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner Cone Prosthesis® 01.00561.317PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Wagner Cone Prosthesis® 01.00561.319Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner Cone Prosthesis® 01.00561.324PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Wagner Cone Prosthesis® 01.00561.221PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Wagner Cone Prosthesis® 01.00561.314Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner Cone Prosthesis® 01.00561.317Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent Wagner Cone Prosthesis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Fracture; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT DUE TO SEQUELAE OF OSTEOCHONDRITIS. THIS PROTHESIS SHOWED EARLY LOOSENING WITH PAIN ON THE RIGHT SIDE, REQUIRING REVISION SURGERY APPROXIMATELY 3 YEARS POST IMPLANTATION. DURING THE PROCEDURE, THE SURGEON NOTED THAT THE FEMORAL STEM HAD BROKEN AT ITS DISTAL END AND THAT A FRAGMENT MEASURING APPROXIMATELY 1 CM REMAINED IN THE FEMORAL SHAFT. A FEMOROTOMY WAS PERFORMED TO EXTRACT THE FRAGMENT, WITH NO FURTHER CONSEQUENCES FOR THE PATIENT. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDE.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain
MAUDE report 24157841 ↗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 ↗InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT. SUBSEQUENTLY, PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO STEM LOOSENING. HIP ASPIRATION CULTURES SHOWED NO GROWTH WHICH CORRELATES WITH BONE SCAN RESULTS THAT INDICATE LOOSENING WITH INFECTION UNLIKELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening; Bacterial Infection; Bursitis; Medical device site infection; Pain; Scar Tissue; Septic loosening; Swelling/ Edema; Synovitis
MAUDE report 23350409 ↗MalfunctionApr 22, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT TRIAL HEADS GOT STUCK ON WAGNER CONE TRIALS AND REAL IMPLANT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21883977 ↗InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT HIP REVISION POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21421607 ↗InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO PAIN, THE PATIENT WAS SCHEDULED FOR A REVISION OF THE FEMORAL STEM WITH ARCOS REVISION STEM. THE WAGNER STEM THAT WAS REMOVED WAS NOT DAMAGED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Pain
MAUDE report 19403549 ↗MalfunctionMar 15, 2023Positioning Problem; Positioning Problem
IT WAS REPORTED THAT DURING THE SURGERY OF THE RIGHT HIP AT TIME OF IMPLANTATION THE IMPLANT SIZE 16 MM WENT IN LOOSE SO THE SURGEON CHANGED TO SIZE 18 MM IMPLANTED AND WENT IN WITHOUT ISSUE. DUE DILIGENCE WAS PERFORMED; TO DATE WHATEVER ADDITIONAL INFORMATION RECEIVED, ALL HAVE BEEN INCLUDED IN THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 16545990 ↗MalfunctionMar 15, 2023Positioning Problem; Positioning Problem
IT WAS REPORTED THAT DURING THE SURGERY OF THE RIGHT HIP AT TIME OF IMPLANTATION THE IMPLANT SIZE 16 MM WENT IN LOOSE SO THE SURGEON CHANGED TO SIZE 18 MM IMPLANTED AND WENT IN WITHOUT ISSUE. DUE DILIGENCE WAS PERFORMED; TO DATE WHATEVER ADDITIONAL INFORMATION RECEIVED, ALL HAVE BEEN INCLUDED IN THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 16545941 ↗InjuryOct 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THERE WAS AN ISSUE RELATED TO FEMORAL STEM AND AN UNKNOWN MEDICAL PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
Patient problems: Insufficient Information
MAUDE report 15637797 ↗MalfunctionOct 11, 2022Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY, THE TRIAL HEAD BECAME JAMMED ON THE STEM. THE HEAD WAS EVENTUALLY REMOVED AFTER 10 MINUTES, AND SURGERY WAS COMPLETED NORMALLY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15578928 ↗MalfunctionOct 7, 2022Positioning Problem; Positioning Problem
IT WAS REPORTED THAT DURING THE SURGERY OF THE RIGHT HIP AT TIME OF IMPLANTATION THE IMPLANT SIZE 16 MM WENT IN LOOSE SO THE SURGEON CHANGED TO SIZE 18 MM IMPLANTED AND WENT IN WITHOUT ISSUE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 15561450 ↗InjurySep 16, 2022Fracture; Fracture
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY OF LEFT HIP DUE TO FRACTURE OF FEMORAL STEM. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant
MAUDE report 15435993 ↗InjuryAug 19, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE FEMUR FRACTURED WHILE IMPLANTING CONE STEM. CABLES WERE USED TO FIX THE FRACTURE INTRAOPERATIVELY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Bone Fracture(s)
MAUDE report 15256592 ↗InjuryJul 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT RIGHT COXARTHROSIS OCCURRED. PATIENT UNDERWENT A REVISION OF THE INSERT FOR WEAR, AND THE STEM FOR MOBILIZATION APPROXIMATELY 12 YEARS AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 14942131 ↗MalfunctionNov 26, 2021Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated
Other Zimmer GmbH products
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- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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