MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TOTAL HEAD; HIP PROSTHESIS

Catalog Number 721028000

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It was reported that the sterile package was noted to be damaged while peeling off the cover for use.The scrub nurse refused the implant for sterility reasons.Surgery was completed with another device.

Manufacturer Narrative

This report is being amended to reflect changes.This report will be amended when our investigation is complete received, not yet evaluated.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The ball head and it's packaging was returned and from the evaluation of the returned product determined that the peel tab of the inner tyvek was sealed between the outer tyvek and cavity and when the outer tyvek was removed, the inner tyvek partially delaminated.Dhr was reviewed and no discrepancies were found.Upon further review, the reported issue may be caused when operator didn't fold the peel tab of inner tyvek.So the root cause for the reported issue can be manufacturing deficiency.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER TOTAL HEAD
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5857039
• MDR Text Key: 51484870
• Report Number: 0001822565-2016-02715
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK954800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 721028000
• Device Lot Number: 62267875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2013
• 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