MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION® HIP STEM, UNCEMENTED, ø 19/225, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent hip revision surgery due to the loosening, difficulty in walking and pain in unknown timeframe after initial surgery.Due diligence is completed and no further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ brazil.This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.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 19/225, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16767592
• Report Number: 0009613350-2023-00166
• Device Sequence Number: 6397713
• Product Code: LZO
• UDI-Device Identifier: 00889024593367
• UDI-Public: (01)00889024593367(17)250730(10)3026402
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K043356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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: Health Professional
• Device Expiration Date: 07/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.219
• Device Lot Number: 3026402
• 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: 03/21/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male