MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VHS VARIABLE ANGLE 4H PLATE; TRAUMA IMPLANTS

Catalog Number 200104

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 05/14/2015

Event Type  Injury  

Manufacturer Narrative

Product was not available for return.Root cause attributed to patient conditions.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional related issues for this item.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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that the patient was implanted on an unknown date with a biomet vhs plate and screw in an attempt to correct a femoral neck fracture.Subsequently, the vhs plate was removed and replaced with a total hip system on (b)(6) 2015 due to femoral head collapse.

• Brand Name: VHS VARIABLE ANGLE 4H PLATE
• Type of Device: TRAUMA IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6958579
• MDR Text Key: 89630472
• Report Number: 0001825034-2017-09145
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964880
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2017

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 200104
• Device Lot Number: 142930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2013
• 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): Required Intervention