MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG E1 LINER 36MM G; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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 surgery, the liner did not seat into the corresponding cup.There was an approximate 10 minute delay to obtain an alternate product.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.D4: udi#:(b)(4).The event was confirmed with product returned.Visual inspection found the outer radius of the liner to be free of scratching and damage.The barb has been deformed in one location.Gouging was observed on the outside of the elevated portion of the liner.Dhr was reviewed and no discrepancies relevant to the reported event 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 10 DEG E1 LINER 36MM G
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10491686
• MDR Text Key: 205714472
• Report Number: 0001825034-2020-03437
• 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: 11/04/2020

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: 01/11/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000898
• Device Lot Number: 6455505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: 010000706 G7 SHELL LOT#: 6469777.; CAT#: 010000708 G7 SHELL LOT#: 6469444.