MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SYSTEM OSSEOTI 3 HOLE SHELL 52MM E; PROTHESIS, HIP

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient underwent a hip arthroplasty on an unknown date and is being considered for a revision in approximately one month.It was reported that the original surgeon reamed out the posterior wall of the acetabulum, the cup was then implanted with no posterior support, and a void was left between the implant and anterior bone.There was no issue with the implant.No additional information.

Manufacturer Narrative

Cmp-09(b)(4).24966 d10: cat# 010000999 lot# 7612322 g7 screw 6.5mm x 30mm.Cat# 30103605 lot# 66231661 g7 vit e neutral lnr 36mm.Cat# 00877503602 lot# 3170581 biolox delta fem head, 36mm, +0mm.Cat# 574201060 lot# 3158250 avenir cmpl ha std col size 6.Product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034-2024-00676.

• Brand Name: G7 ACETABULAR SYSTEM OSSEOTI 3 HOLE SHELL 52MM E
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18865616
• MDR Text Key: 337209612
• Report Number: 0001825034-2024-00673
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00887868355882
• UDI-Public: (01)00887868355882(17)330914(10)66005192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010244
• Device Lot Number: 66005192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other