MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION STEM 15/225; PROSTHESIS, HIP

Catalog Number	0100102215
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Aseptic loosening (4883)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
(b)(4).D10.Freedom std face liner sz 24 item# 11-107323 lot# 998600.Constrained head 12/14 taper 36 mm diameter +6 mm neck length for use with freedom constrained liners item# 802403605 lot# 3103183.Versys heritage 16x145mm st item# 00-7857-016-00 lot# 66430076.Vh prox cntrlzr sleeve 16 item# 00-7858-016-57 lot# 65803836.Distal centralizer 13mm item# 00-7859-013-00 lot# 65346636.Ringloc+ replacement ring sz24 item# 106024 lot# 721900.Biolox delta head 12/14 36x0 item# 00-8775-036-02 lot# 2968780.Cable ready gtr cocr cable item# 00-2232-004-18 lot# 64277340.Cable ready gtr cocr cable item# 00-2232-004-18 lot# 64324841.Cable ready gtr cocr cable item# 00-2232-004-18 lot# 64245449.Epoly rlc 36mm 10deg sz24 sz24 item# ep-105894 lot# 159620.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b7, g3, g6, e1, h2, h6, h11.
Event or Problem Description
It was reported that the patient had an initial right total hip arthroplasty on an unknown date in 2016 with an unknown product.After this, had a 1st revision due to loosening approximately 3 years post-implantation.Subsequently, approximately 6 years later, underwent a 2nd revision due to loosening and implant fracture from falling.During the procedure the stem was grossly loose with the distal portion of the stem well fixed.Shell was well fixed and remained implanted.The stem, head and liner were exchanged without complications.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.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.Two ap x-rays (of which one with incomplete overview of the stem) and a lateral one were provided and reviewed.All the radiographs are undated but allegedly taken before second revision surgery.Based on the provided images, a fracture of the stem in the distal area can be confirmed.Sclerotic lines and a gap between the device and the bone are visible in all provided images, especially in the lateral view.However, due to the lack of other radiographs taken on previous time points, it cannot be established if this was already present at the moment of implantation, or developed during the time in vivo.Based on the available information, the reported event can be confirmed, but a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: WAGNER SL REVISION STEM 15/225
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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: 22108066
• Report Number: 0009613350-2025-00386
• Device Sequence Number: 17960839
• Product Code: JDI
• UDI-Device Identifier: 00889024485198
• UDI-Public: (01)00889024485198(17)220531(10)2912687
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K871347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: 05/31/2022
• Device Catalogue Number: 0100102215
• Device Lot Number: 2912687
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 07/31/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2017
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 109 KG