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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 08/08/2018

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 during hip surgery, the liner would not assemble.The procedure was completed with a second device.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection identified damages to the scallops as well as the locking features of the liner.There were also damages in the form of scratches on the rim of the liner.These damages were likely caused during an attempt to the seat the liner in the shell and during removal.There are circular indentation on the outer diameter of the liner likely caused by the screw.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 ACETABULAR LINER HIGH WALL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7845986
• MDR Text Key: 119663302
• Report Number: 0001825034-2018-08692
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000935
• Device Lot Number: 6099135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 11-363662 638500 36MM COCR MOD HD STD; 110017103 6289089 G7 FINNED 3 HOLE SHELL 52E; X11-170312 393460 INTEGRAL/XLAT POR PROFILE 12MM
• Patient Age: 71 YR