MAUDE Adverse Event Report: ZIMMER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, ø 14/190, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	0100101914
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Radiolucent Lines (4848); Aseptic loosening (4883)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a third left hip revision approximately 10 months post implantation due to aseptic loosening.The patient had previously undergone an initial left total hip arthroplasty on an unknown date.Approximately 3 months post implantation, the patient developed an infection that was treated with irrigation and debridement, after which the infection reportedly cleared.Approximately 10 months post implantation, during the revision procedure, the acetabular cup was found to be grossly loose and was removed without difficulty; the femoral stem was also noted to be loose.All implants were revised without intraoperative complications.No environmental factors were reported to have contributed to the event.The patient was revised with no known complications or adverse consequences reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) 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 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b7, d10, g3, g6, h2, h11.Corrected: b3, e1 (email address), h5, h6 (health effect - clinical codes).D10.Unknown 24 +5 freedom poly item# unknown lot# unknown.Unknown 36mm -6 freedom head item# unknown lot# unknown.Zb 40gm c cement item# 110035368 lot# unknown.
Event or Problem Description
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, d1, d4, d10, g3, g6, h2, h3, h11.D10.24 +5 freedom poly item# 11-107023 lot# 66961702.36mm -6 freedom head item# 802403601 lot# 3206835.Bone screw 6.5x70 self-tap item# 00625006570 lot# 65664822.Zb 40gm cement item# 110035368 lot# unknown.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
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.The reported event was confirmed by review of op notes.Medical records were provided and reviewed by a health care professional.The review identified the femoral stem was loose and removed without difficulty, there was no pus, abductors intact stable dual mobility, leg lengths lengthened as much as possible.Infection was noted to be clear at time of surgery.Culture results - no growth.No product was returned or pictures provided; a product evaluation could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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 HIP STEM, UNCEMENTED, ø 14/190, TAPER 12/14
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23430323
• Report Number: 0009613350-2025-00837
• Device Sequence Number: 15517101
• Product Code: LZO
• UDI-Device Identifier: 00889024593459
• UDI-Public: (01)00889024593459(17)290115(10)3187514
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/31/2026

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 Catalogue Number: 0100101914
• Device Lot Number: 3187514
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 11/24/2025; 03/30/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/17/2025; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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.; SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White