MAUDE Adverse Event Report: ZIMMER GMBH WAGN CONE PROSTHESIS 125 20; WAGNER HIP IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
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 will be submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Event or Problem Description
No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1, a2, a3, b5, g3; h2; h3.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.
Event or Problem Description
It was reported that a patient had a revision surgery of the femoral stem with arcos revision stem due to pain while lifting weights.The wagner stem that was removed was not damaged.Due diligence has been completed for this complaint; to date all available additional information has been received.
Event or Problem Description
No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of provided pictures identified a femoral stem with scratch marks at the level of the neck.The stem is intact and not fractured.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.One single ct slice was received for investigation.The review identified a total hip arthroplasty.The neck of the stem shows a dark line that could explain the possible fracture that was reported.However, a single ct slice is not complete and therefore an assessment cannot be performed.Based on the available information, the reported event cannot be confirmed.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: WAGN CONE PROSTHESIS 125 20
• Common Device Name: WAGNER HIP IMPLANT
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19403549
• Report Number: 0009613350-2024-00194
• Device Sequence Number: 7744421
• Product Code: LZO
• UDI-Device Identifier: 00889024485082
• UDI-Public: (01)00889024485082(17)251130(10)3050355
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K191781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/31/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 0100561220
• Device Lot Number: 3050355
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 06/13/2024; 07/25/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/08/2024; 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male