MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 10 DEG ARCOMXL LINER 40MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: g7 osseoti multihole 62mm h l 62mm h cat# 110010269 lot# 6285532.The device will not be returned for analysis, per hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02009.

Event Description

It was reported that during the revision, the osseoti multi shell was implanted per technique without issue.An attempt was made to insert the 10 degree 40mm arc liner per technique.While the liner appeared to the surgeon eye to be satisfactory, a tug on the liner lip immediately resulted in the liner coming out of the shell.After multiple attempts to implant the liner, and after checking the liner for damage, it was determined that the liner was defective.A 10 degree 36mm liner was then implanted, yet same result as the prior liner, no success.The noted shell was removed and a 4 hole osseoti same size was implanted with screws to follow.The 10 degree 36mm liner previously used was inspected for damage and implanted, without issue.Attempts have been made and additional information on the reported event is unavailable at this time.

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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 10 DEG ARCOMXL LINER 40MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10097696
• MDR Text Key: 198305091
• Report Number: 0001825034-2020-02006
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: N/A
• Device Catalogue Number: 010000788
• Device Lot Number: 3787184
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1