MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL ARCOMXL LNR 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 010000666 g7 pps ltd acet shell 58g 6645900; 010000937 g7 hi-wall e1 liner 36mm g 6434573.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04230, 0001825034 - 2020 - 04231.

Event Description

It was reported that during total hip arthroplasty the surgeon implanted the cup and screw and attempted to implant the liner and it would not seat/lock in.Another liner was opened and attempted to be implanted and it would not seat/lock in either.Cup rim was checked both times for interference and there was none.The screw and cup were removed and competitor's product implanted.No additional information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.One g7 pps ltd acet shell 58g item# 010000666 lot# 6645900, one g7 hi-wall e1 liner 36mm g item# 010000937 lot# 6434573, and one g7 hi-wall arcomxl lnr 36mm g item# 010000820 lot# 6044608 were returned and evaluated.Upon visual inspection the shell has scuffing near the square feature.Liner 6044608 has scuffing on the outside diameter and damage to the locking feature.Liner 6434573 has scuffing on the outside diameter with no visual damage to the locking feature.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

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

• Brand Name: G7 HI-WALL ARCOMXL LNR 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10919961
• MDR Text Key: 218704782
• Report Number: 0001825034-2020-04232
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000820
• Device Lot Number: 6044608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1