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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 650-0661 2017010160, unknown cup, unknown stem.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient was revised approximately two years post implantation due unknown reason.The head and liner were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported patient was revised approximately two years post implantation due to infection.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: G7 HI-WALL E1 LINER 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9233658
• MDR Text Key: 163754068
• Report Number: 0001825034-2019-04720
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000936
• Device Lot Number: 6130678
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention