MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 LONGEVITY HIGH WALL 32MM C; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during a total hip arthroplasty, that the surgeon stated the acetabular liner wouldn't seat all the way in the acetabular shell.Another liner was used to complete the procedure.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.A g7 longevity liner was returned.Visual evaluation identified the following: there was damage on the outer spherical surface.All devices that were sent to finished goods inventory were inspected on a cmm at the time of manufacture and were found to be conforming to print specifications.No other damages were noted and no further evaluation could be performed with the returned product.Device history record (dhr) 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.

• Brand Name: G7 LONGEVITY HIGH WALL 32MM C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11243836
• MDR Text Key: 229138458
• Report Number: 0001822565-2021-00256
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K190660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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 Model Number: N/A
• Device Catalogue Number: 20123203
• Device Lot Number: 64880210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1