MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES 52 MM O.D. WITH CALCICOAT CERAMIC COATING; PROSTHESIS HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: item# 00641802802 al fm hd 28 x 0mm (12/14) lot# 52887200; item# 00632005028 liner 20 degree elevated rim 28 mm i.D.For use with 50/52/54 mm o.D.Shells lot# 79803700; item# 65786200000 set, fm taper 19/20 hatcp lot# 63131000.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported surgeon was unable to take liner out of the cup as locking ring was jammed.Liner was cut and locking ring removed from cup.Locking ring replaced.Attempts were made to obtain additional information; however, none is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: reported event was confirmed by provided photographs.Visual inspection of photographs determined that the locking ring was bent.As reported, the liner was cut and broken.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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

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

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 52 MM O.D. WITH CALCICOAT CERAMIC COATING
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8106937
• MDR Text Key: 128443183
• Report Number: 0001822565-2018-06470
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K980711
• 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
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2006
• Device Model Number: N/A
• Device Catalogue Number: 65620005222
• Device Lot Number: 78002200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2001
• 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