MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIV 2-HOLE SHL 56MM LNR SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult To Position (1467)

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

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Telephone number: (b)(6).Foreign: the event occurred in (b)(4).The device was not returned for evaluation as it remains implanted.Review of the device history records (dhr) identified a deviation during manufacturing process; the nonconformance was reworked and accepted.Review of complaint history found no additional related issues for this item.Without the opportunity to examine the product the complaint was not confirmed and root cause was not determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.The risk table states: "improper assembly of components." following review, no new risks were identified.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that during a right total hip procedure the liner would not assemble correctly with the shell.The liner had movement of more than 1mm when pressure was applied to the edge.No adverse events have been reported as a result of the malfunction.

• Brand Name: UNIV 2-HOLE SHL 56MM LNR SZ 24
• 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: 7015030
• MDR Text Key: 92529009
• Report Number: 0001825034-2017-10102
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK030055
• 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
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-103656
• Device Lot Number: 605930
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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
• Patient Age: 56 YR
• Patient Weight: 60