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

Model Number N/A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon could not successfully impact poly insert.The surgical technique was followed.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Complaint sample was evaluated and the reported event was confirmed.Two (2) g7 hi-wall arcomxl lnr 36mm f with part # 010000819 from lot 3955788 were returned and evaluated against the complaint.Visual inspection found damage common to both liners.The barbs are scraped such that a poly strand protrudes from the liner.The side walls are gouged.The scallops of the elevated portion of the liners are deformed from making contact with the shell at the time of impaction.One liner shows an indentation on the outer radius likely caused by making contact with a screw that was not seated properly in the shell.The outer radius of the other liner was free of any damage.Dimension analysis was not possible because of the impact on the liners.The likely condition of the product is conforming when it left zimmer biomet.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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: 0001825034-2017-05840, 0001825034-2018-02424.

• Brand Name: G7 ACETABULAR LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6772210
• MDR Text Key: 82080339
• Report Number: 0001825034-2017-05840
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/29/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000819
• Device Lot Number: 3955788
• Other Device ID Number: (01) 0 0880304 52609 9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1