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

Catalog Number 00500104426

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, not yet evaluated.

Event Description

It is reported that the liner was unable to be assembled to the cup.

Manufacturer Narrative

Concomitant medical product(s): shell 44 mm o.D.Cat: 00500104400 lot: 63283125.Complaint sample was evaluated and the reported event was unable to be confirmed.The devices were received fully assembled.The liner is fully seated in the shell.Damage is seen around the entire perimeter of the liner and poly lock ring.The femoral head can be rotated within the liner/lock ring.One of two tabs of the metal lock ring is seized in the lock ring grove of the shell.The condition of the returned devices will not allow for an accurate dimensional analysis.Device history record was reviewed and no discrepancies were found.The complaint is non-verifiable as the returned parts were assembled.However, they do exhibit damage indicative of use.A definitive root cause cannot be determined with the information provided.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.

Event Description

It is reported that the liner was unable to be assembled to the cup.There was a 60 minute delay in the procedure.Another cup and liner were used to complete the procedure.No further patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

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 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 46582-0708 ; 5745273773
• MDR Report Key: 5771928
• MDR Text Key: 48837659
• Report Number: 0002648920-2016-00915
• 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: 04/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 00500104426
• Device Lot Number: 63266610
• Other Device ID Number: (01) 00889024115316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: 03/29/2018; 03/30/2018
• Supplement Dates FDA Received: 03/30/2018; 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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 Outcome(s): Hospitalization