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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 110010263, g7 osseoti multihole 50mm d, 6319835.(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 g7 e1 liner could not be fixed to g7 osseoti acetabular shell.The surgery was finished with backup liner.No additional information available.

Event Description

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

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.The liner was returned and evaluated.Visual inspection identified damage on the rim of the liner likely caused during an attempt to seat the liner into the shell.There were circular indentation on the outer diameter on the liner likely caused from the screw.Dimensional analysis cannot be performed due to its impaction and the resulting damage.Device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 NEUTRAL E1 LINER 32MM D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7922435
• MDR Text Key: 122196973
• Report Number: 0001825034-2018-09144
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• 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: 03/19/2019

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: 02/24/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000848
• Device Lot Number: 6237987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1