MAUDE Adverse Event Report: ZIMMER BIOMET BIOMET G7 EFFICIENT TRAY / STRAIGHT INSERTER THREADED SHAFT; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER, + ADDITIVE

Catalog Number 110003452

Device Problems Break (1069); Component Missing (2306)

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

Event Date 06/22/2020

Event Type  malfunction  

Event Description

Patient in for a hip revision, real stem and proximal.Tip broke off screw driller.Physician believed it to be lodge in trial head.The tip was not identified via x-ray as piece is approx 3mmx3mm.Fda safety report id# (b)(4).

• Brand Name: BIOMET G7 EFFICIENT TRAY / STRAIGHT INSERTER THREADED SHAFT
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER, + ADDITIVE
• Manufacturer (Section D): ZIMMER BIOMET; warsaw IN 46581
• MDR Report Key: 10250079
• MDR Text Key: 198340323
• Report Number: MW5095430
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110003452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1