MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 40MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 010000866 g7 neutral e1 liner 40mm h lot# 3517347, item# 010000668 g7 pps ltd acet shell 62h lot# 6171981, item# 00625006525 bone scr 6.5x25 self-tap lot# 63891268, item# 00625006520 bone scr 6.5x20 self-tap lot# 63862345.Complaint sample was evaluated and the reported event was confirmed.Upon visual inspection both liners show circular indentations on the outside radius.The locking feature on both of the liners show damage and deformation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04308.

Event Description

It was reported during total hip arthroplasty, the liner would not seat as it remained proud opposite of single screw placement.Attempts were made to obtain additional information; however, none was available.

• Brand Name: G7 NEUTRAL E1 LINER 40MM H
• 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: 7646100
• MDR Text Key: 112848401
• Report Number: 0001825034-2018-04309
• 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
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000866
• Device Lot Number: 6181147
• Other Device ID Number: (01) 0 0880304 526501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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