MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION STEM 17/225; PROSTHESIS, HIP

Catalog Number	01.00102.217
Medical Device Problem Codes	Biocompatibility (2886); Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Skin Discoloration (2074); Deformity/ Disfigurement (2360); Impaired Healing (2378); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
(b)(4).D10: 56mm o.D.Size kk porous uncemented with multi-holes shell use with kk liners item: 00875705602, lot: 64819064, femoral head sterile 12/14 taper, item: 00801803601, lot: 65142250, 36mm i.D.Size kk elevated rim liner use with 56mm o.D.Size kk shell, item: 00875201236, lot: 64933610, bone screw self-tapping 6.5 mm dia.20 mm length, item: 00625006520, lot: 65140227, bone screw self-tapping 6.5 mm dia.30 mm length, item: 00625006530, lot: 64825892, bone screw self-tapping 6.5 mm dia.25 mm length, item: 00625006525, lot: 65135465.G2: foreign - event occurred in india.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: WAGNER SL REVISION STEM 17/225
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25278455
• Report Number: 0009613350-2026-00265
• Device Sequence Number: 10085443
• Product Code: LZO
• UDI-Device Identifier: 00889024485228
• UDI-Public: (01)00889024485228(17)260819(10)3080476
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/19/2026
• Device Catalogue Number: 01.00102.217
• Device Lot Number: 3080476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male