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

Catalog Number 010000928

Device Problem Difficult to Insert (1316)

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

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted concomitant medical products: unknown cup.Report source: (b)(6).

Event Description

It was reported that during a hip procedure the high wall liner would not engage in cup.The surgeon cleared the cup from any tissue or bone that would be preventing the liner to seat.After numerous attempts a new high wall liner was opened and engaged without issue.As a result of the malfunction there was a delay of approximately 30 minutes.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

One g7 hi-wall e1 liner 32mm f item# 010000928 lot# 6495786 was returned and evaluated.Upon visual inspection there is indentation marks on the outside radius and on the scallop location.One scallop has also been separated into two pieces with both still attached to the device.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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.

Event Description

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

• Brand Name: G7 HI-WALL E1 LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11095861
• MDR Text Key: 224393610
• Report Number: 0001825034-2020-04443
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Catalogue Number: 010000928
• Device Lot Number: 6495786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR