Wagner SL RevisionRecalls & reported problems across all models
Zimmer GmbH · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 33 models of Wagner SL Revision by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2018 and Aug 26, 2026 — classified as 48 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Fracture” (36 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 SL Revision problems
Device problems
- Fracture36
- Adverse Event Without Identified Device or Use Problem6
- Loosening of Implant Not Related to Bone-Ingrowth6
- Mechanical Jam6
- Mechanical Problem5
- Appropriate Device Problem Term/Code Not Available4
- Difficult to Remove3
- Material Integrity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information13
- Failure of Implant11
- Bone Fracture(s)9
- No Information8
- Pain8
- Ambulation or Postural Difficulties5
- Aseptic loosening4
Wagner SL Revision models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Wagner SL Revision® 01.00109.805Prosthesis, hip, semi-constrained, metal/polymer, cemented7 reports
- Wagner SL Revision® 01.00102.217Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6 reports
- Wagner SL Revision® 01.00109.116Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- Wagner SL Revision® 01.00109.809Prosthesis, hip, semi-constrained, metal/polymer, cemented5 reports
- Wagner SL Revision® 01.00109.115Prosthesis, hip, semi-constrained, metal/polymer, cemented4 reports
- Wagner SL Revision® 01.00102.215Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4 reports
- Wagner SL Revision® 01.00109.808Prosthesis, hip, semi-constrained, metal/polymer, cemented3 reports
- Wagner SL Revision® 01.00109.806Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Wagner SL Revision® 01.00109.810Prosthesis, hip, semi-constrained, metal/polymer, cemented2 reports
- Wagner SL Revision® 01.00102.219Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Wagner SL Revision® 01.00102.214Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Wagner SL Revision® 01.00102.219Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Wagner SL Revision® 01.00101.914Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented2 reports
- Wagner SL Revision® 01.00109.117Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00109.118Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00109.119Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00109.802Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00109.807Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00103.020Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00101.916Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00101.918Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00102.616Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.218Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.215Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.614Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.218Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.219Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.220Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00102.222Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00101.915Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00101.916Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 report
- Wagner SL Revision® 01.00101.919Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- Wagner SL Revision® 01.00101.920Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Recent Wagner SL Revision adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported from a clinical study that a patient underwent a right hip stage I revision arthroplasty with final implants used as a spacer for infection. Subsequently, a stage II revision arthroplasty was performed; during which, the gross aseptic loosening was noted in the cup and stem. All components were revised without complication. The patient entered the current study at the stage II revision with no further concerns or complications reported.Attempts have been made and no further information has been provided.
Patient problems: Aseptic loosening
MAUDE report 50453557 ↗InjuryMay 26, 2026Biocompatibility; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 YEAR POST IMPLANTATION DUE TO HAVING PAIN AND DIFFICULTY AMBULATING. SUBSEQUENTLY, THE PATIENT CONTINUED TO EXPERIENCE PAIN, DIFFICULTY AMBULATING, SWELLING, AND IMPAIRED HEALING. THE PATIENT ALLEGES LEG LENGTH DISCREPANCY AND A SYSTEMIC ALLERGIC REACTION TO THE IMPLANT COATING. ADDITIONALLY, THE PATIENT ALLEGES THAT THE POSTERIOR SCREW OF THE CUP IS MIGRATING AND PENETRATING THE GLUTEN MUSCLES AND CAUSING FEMORAL AND SCIATIC NERVE DAMAGE AND NEUROPATHY. NO MEDICAL RECORDS HAVE BEEN PROVIDED THUS FAR. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Deformity/ Disfigurement; Fever; Hypersensitivity/Allergic reaction; Impaired Healing; Itching Sensation; Loss of Range of Motion; Nerve Damage; Pain; Skin Discoloration; Swelling/ Edema; Unequal Limb Length
MAUDE report 25278455 ↗InjuryOct 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Pain; Radiolucent Lines
MAUDE report 23430323 ↗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 ↗MalfunctionApr 23, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A KIT INSPECTION, IT WAS NOTED THAT THE THREAD OF THE ROD IS BROKEN OFF IN THE SHAFT. 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 21892183 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Thrombosis/Thrombus
MAUDE report 21700939 ↗InjuryMar 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Aseptic loosening; Bone Fracture(s); Pain; Radiolucent Lines; Unequal Limb Length
MAUDE report 21699718 ↗InjuryOct 24, 2024Fracture; Fracture
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Extraskeletal ossification; Failure of Implant; Osteolysis
MAUDE report 20529934 ↗InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION AT THIS TIME.
Patient problems: Bone Fracture(s)
MAUDE report 19691162 ↗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 ↗MalfunctionMar 8, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18865592 ↗InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION APPROXIMATELY 14 MONTHS LATER DUE TO LOOSENING. LATER, APPROXIMATELY 8 YEARS LATER, A SECOND REVISION WAS PERFORMED FOR METALLOSIS AND A FRACTURED STEM. SUBSEQUENTLY, APPROXIMATELY 1 MONTH LATER, THE PATIENT FELL AND EXPERIENCED A FEMORAL PERIPROSTHETIC FRACTURE AND UNDERWENT AN ADDITIONAL PROCEDURE WHERE A STABLE DOUBLE PLATE OSTEOSYNTHESIS WAS PERFORMED. IT IS UNCLEAR AT THIS TIME IF IMPLANTS WERE REVISED AS NO FURTHER DETAILS HAVE BEEN PROVIDED. DILIGENCE IS COMPLETE AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAVE BEEN PROVIDED.
Patient problems: Bone Fracture(s); Fall
MAUDE report 18730414 ↗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 ↗InjuryJun 20, 2023Unstable; Patient Device Interaction Problem; Unstable; Patient Device Interaction Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: High metal ion levels
MAUDE report 17161103 ↗MalfunctionJun 19, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A TRIAL OF A STEM, THE SET SCREW BROKE WHILE USING THE SLAPHAMMER. THE EXACT CAUSE OF THE BREAKAGE IS UNCERTAIN, BUT IT IS POSSIBLE THAT THE STEM WAS OVERSIZED OR NOT REAMED SUFFICIENTLY DISTALLY. AT THE TIME OF THE BREAK, THE DEVICE WAS LOCATED INSIDE THE FEMORAL CANAL. TO REMOVE THE DEVICE, AN OSTEOTOMY WAS REQUIRED. IT IS LIKELY THAT DEVIATING FROM THE RECOMMENDED TECHNIQUE, SPECIFICALLY OVER-REAMING OR INADEQUATE REAMING DISTALLY, CONTRIBUTED TO THIS INCIDENT. THE OVERALL DELAY CAUSED BY THIS EVENT WAS APPROXIMATELY ONE HOUR. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17152026 ↗
Other Zimmer GmbH products
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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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