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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: unknown cup.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05268.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 seat into the cup.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

Manufacturer Narrative

The reported liner was returned and evaluated.Upon visual inspection the locking feature shows shavings and indentations.There was no damage to the outside radius of the device.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. .

Event Description

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

• Brand Name: G7 10 DEG ARCOMXL LINER 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9368645
• MDR Text Key: 194456423
• Report Number: 0001825034-2019-05267
• 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,Followup
• Report Date: 02/21/2020

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: 04/17/2024
• Device Model Number: N/A
• Device Catalogue Number: 010000780
• Device Lot Number: 6524725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/02/2019; 02/20/2020
• Supplement Dates FDA Received: 12/23/2019; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1