MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 48C; ACETABULAR SHELL

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 010000925, g7 hi-wall e1 liner 32mm c, lot# 6191600; item# 010000808, g7 hi-wall arcomxl lnr 32mm c, lot# 6228535; item# unknown, unknown stem, lot# unknown; item# unknown, unknown head, lot# unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -02197; 0001825034 -2019 -02204.

Event Description

It was reported during a total hip arthroplasty procedure, the surgeon was unable to seat the liner after multiple attempts.The surgeon tried to seat a different liner and this was unsuccessful as well.The implanted cup had to be removed and a competitor cup and liner was implanted.A twenty minute surgical delay was noted.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi#:(b)(4).The event was confirmed with product received.Upon visual inspection liner is impacted into shell and could not be removed, there is a gap that can be seen in the screw holes of the shell.Review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 48C
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8624214
• MDR Text Key: 145516548
• Report Number: 0001825034-2019-02205
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 010000661
• Device Lot Number: 6326438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention