MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 62H; HIP PROSTHESIS

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 10/23/2018

Event Type  Injury  

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.Concomitant medical products: item # 010000743, g7 neutral arcomxl lnr , lot # 3822583.Item # 010000743, g7 neutral arcomxl lnr , lot # 3517308.Item # 010000743, g7 neutral arcomxl lnr , lot # 3575886.Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-10777, 0001825034-2018-10779, 0001825034-2018-10780.

Event Description

It was reported that multiple liners would not seat in cup.After the third liner, the surgeon removed the cup, and implanted an alternate cup.The third liner was then used and seated successfully.The malfunction caused a 45 minute surgical delay.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection found surface scratching on the rim and inner radius of the shell.The inner radius also exhibits a gouge consistent with the attempt to remove a liner with a screw.No significant damage was noted on the locking groove.Foreign debris was observed on the outer radius.No dimensional analysis will be conducted at this time.100% automated inspection at the time of production shows the device(s) met all dimensional specifications.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.

Event Description

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

• Brand Name: G7 PPS LTD ACET SHELL 62H
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8086648
• MDR Text Key: 127807004
• Report Number: 0001825034-2018-10778
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000668
• Device Lot Number: 6081830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention