MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 52E; PROTHESIS HIPS

Catalog Number 010000663

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet.The complaint of two of the screw hole covers unable to be removed was confirmed upon evaluation of the product.The 3rd hex drive thread was inspected for thread damage and checked using a small plug then torquing to the correct torque.The plug was easily removed after this test with no sticking or cross threading taking place.The shell was most likely conforming when it left the facility due to no discrepancies on the manufacturing records being found and that the current shell assembly work instructions clearly shows how to fit the hex drive plugs and that the torquing of the screws is set and cannot be changed.Root cause of the failure of the hex drive screws being cross-threaded cannot be determine.Review of complaint history found no additional related issues for the g7 pps limited hole shells.Review of device history records found these units were released to distribution with no deviations or anomalies.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 left total hip arthroplasty on (b)(6) 2016, the surgeon was unable to remove two of the three screw hole covers in the g7 shell because the hex hole in the cover had stripped.No further information has been provided.

• Brand Name: G7 PPS LTD ACET SHELL 52E
• Type of Device: PROTHESIS HIPS
• 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: 6955582
• MDR Text Key: 90440607
• Report Number: 0001825034-2017-08917
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000663
• Device Lot Number: 3666980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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: 59 YR
• Patient Weight: 66