MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET G7 LINER; HIP PROSTHESIS

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 10/11/2017

Event Type  Injury  

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 medical products: item # 110017104, finned cup, lot # 6061019, item # 010000819, liner, lot # 6029243.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-01866, 0001825034-2018-01867, 0001825034-2018-01868.

Event Description

It was reported that multiple liners would not lock into the shell.The event occurred during a primary hip surgery causing a delay greater than 30 minutes.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

This report is being submitted to relay additional information.The device was returned to the manufacturer for evaluation.Upon visual inspection, there was deformation to the scallops and locking feature of the liner.No further measurements were taken as the order was checked 100% during production.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.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

No further event information available at the time of this report.

• Brand Name: BIOMET G7 LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7346620
• MDR Text Key: 102711117
• Report Number: 0001825034-2018-01867
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000811
• Device Lot Number: 6065078
• Other Device ID Number: (01) 0 0880304 52602 0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other