MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER BIPOLAR METAL SHELL; HIP PROSTHESIS

Catalog Number 00500104800

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the liner would not assemble to the shell.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

Product was not returned so no product evaluation could be conducted.Review of device history record identified no deviations or anomalies.This device was used for treatment.A complaint history search identified no other complaints.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Root cause could not be determined with information available.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: ZIMMER BIPOLAR METAL SHELL
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6059827
• MDR Text Key: 58456900
• Report Number: 0002648920-2016-03238
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 00500104800
• Device Lot Number: 62326169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1