MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 36MM H; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: item# 010000938 g7 hi-wall e1 liner 36mm h lot#3940036; 010000668 g7 pourous plasma spray ltd acetabular shell 62h lot#3831312; 00625006525 bone scr 6.5x25 self-tap lot#63953723; 00625006520 bone scr 6.5x20 self-tap lot#63347329.Multiple mdr's filed for this event, please see associated reports:multiple mdr's filed for this event, please see associated reports: multiple mdr's filed for this event, please see associated reports: 0001825034-2018-02346; 0001825034-2018-02344.

Event Description

It was reported that during revision surgery, surgeon was unable to seat liner in shell.Surgeon attempted 2 different liners with no success.Surgeon used different liner/shell to complete surgery.No adverse event noted to patient.Additional information requested and received.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed as visual inspection noted the liners exhibit damage near the scallops and on the face of the rim.Also noted was small damage to the locking feature of the liners which is consistent from the liner impaction.Damage to the screw hole likely occurred during screw insertion.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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: G7 HI-WALL E1 LINER 36MM H
• Type of Device: HIP PROSTHESIS
• 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: 7446651
• MDR Text Key: 106150445
• Report Number: 0001825034-2018-02347
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000938
• Device Lot Number: 3929937
• Other Device ID Number: 0880304527133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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: 76 YR