MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 01/11/2019

Event Type  Injury  

Event Description

It was reported that a total hip study patient (36) underwent revision approximately 3 years post implantation due to painful psoas impingement confirmed by ultrasound.No additional information.

Manufacturer Narrative

(b)(4).Source: foreign: country: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Doi: does the use of the largest possible metal head increase the wear of vitamin e-doped cross-linked polyethylene? two-year results from a randomized controlled trial.10.1302/0301-620x.103b7.Bjj-2020-2064.R1.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00264 and 0001825034-2022-00800.

• Brand Name: G7 NEUTRAL E1 LINER 32MM F
• 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: 14013571
• MDR Text Key: 288589576
• Report Number: 0001825034-2022-00799
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304526365
• UDI-Public: (01)00880304526365(17)201201(10)3697412
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000850
• Device Lot Number: 3697412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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
• Treatment: CAT# 010000664 LOT# 3659134 G7 SHELL; CAT# 163668 LOT# 00J3698303 HEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female