MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 19/190, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 01.00101.919

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that the wagner stem 19/190 sank into the femoral canal whereas the trial implant satisfied the requirement.Surgery completed with wagner stem 19/225.Due diligence is in progress for this complaint; to date, no additional information or product has been received.

Manufacturer Narrative

(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Product was returned for inspection.Visual examination found no signs of damage or usage.A dimensional analysis was performed: a representative feature of the device was taken to further confirm the dimensional correctness of the item.All the measurements taken are conforming to specification.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.All manufactured items were double checked for dimensional correctness.Device is used for treatment.Review of the device manufacturing records for the returned product was performed: at the moment of production all the specifications are satisfied, and the item is conforming.Further measurements have been taken to assess the correctness of the item size: all the dimensions were compliant with specification.The wagner revision stem was returned for investigation, however none of the instruments used for the surgical procedure (reamer and trial stem) were returned, nor item# and lot# were provided.With the available information, no issue was found.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.

Event Description

No further event information available at the time of this report.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 19/190, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 15672014
• MDR Text Key: 302770931
• Report Number: 0009613350-2022-00560
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024593510
• UDI-Public: (01)00889024593510(17)240131(10)2978887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 01.00101.919
• Device Lot Number: 2978887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female