MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 44A; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: catalog# 010000757, g7 10 deg arcomxl liner 28mm a, lot# 3882068.Catalog# 010000913, g7 hi-wall e1 liner 28mm a, lot# 6167725.Catalog# 010000874, g7 10 deg e1 liner 28mm a, lot# 6569774.Catalog# 110003625, biolox delta cer lnr 28mm b, lot# 6022564.Catalog# 650-0830, delta cer fm hd 028/-3.5 12/14, lot# 2019020164.Catalog# 010000660, g7 pps ltd acet shell 46b, lot# 6360904.Catalog# 650-0951, micro tprlc std pc 6mm (12/14), lot# 6594650.Report source : (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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04417, 0001825034-2019-04418, 0001825034-2019-04420.

Event Description

It was reported that the liner would not lock in the acetabular shell.Surgeon used another, larger shell and liner to complete the surgery.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

Udi#: (b)(4).The event was confirmed with product received.Visual inspection found light scratches on the inner radius and rim of the shell.No damage was observed to the locking groove or orientation feature.The apical plug was also returned with the complaint.Dhr was reviewed and no discrepancies relevant to the reported event 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 PPS LTD ACET SHELL 44A
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9146826
• MDR Text Key: 204711093
• Report Number: 0001825034-2019-04419
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: 010000659
• Device Lot Number: 6129679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1