MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Concomitant products: g7 high wall acetabular liner p/n 010000936 l/n 3573808; g7 acetabular shell p/n 010000664 l/n 3625056; echo b-mtrc mp fp so 10 p/n 193010 l/n 176360; cocr modular head p/n 11-363661 l/n 261520.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2016-02954, 0001825034-2017-03874.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further actions are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported even was not provided.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.

Event Description

It was reported that patient had a revision procedure three months post-implantation due to disassociation of the liner from the cup.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Suspect medical device was not explanted.

• Brand Name: G7 ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6639632
• MDR Text Key: 77518030
• Report Number: 0001825034-2017-03874
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 3625056
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• 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 Outcome(s): Hospitalization; Required Intervention