MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 32MM C; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:110010262 lot number:6510144 brand name: unknown g7 acetabular cup.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04539, 0001825034-2019-04541.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 an initial hip arthroplasty, the liner would not assemble with the cup.The surgery was completed with a backup product.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned shell identified dings and gouging to the scallops and locking groove.Scratches were also observed on the rim and around the inner radius.The damage is mostly contained to half of the shell's radius with light scratching on the other half.The liner was also returned and found to be heavily damaged and deformed.The damage was also predominately found on half the liner which corresponds to what was observed on the shell.The barb is deformed such that a thick poly strand protrudes from the liner.Two holes have been drilled through the liner.A portion of a circular indentation is present in 2 locations in the outer radius.Complaint sample was evaluated and the reported event was not confirmed.Device history record 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.

Event Description

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

• Brand Name: G7 NEUTRAL E1 LINER 32MM C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9165751
• MDR Text Key: 200422895
• Report Number: 0001825034-2019-04540
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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: 05/09/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000847
• Device Lot Number: 6535257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1