MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

Legal counsel for patient reported patient was revised approximately 7 years post-implantation allegedly due to unspecified allegations.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Revision operative report indicated the condition of the joint during the procedure was unremarkable.The femoral head and acetabular components were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product- m2a-magnum pf cup 58od/52id catalog# us157858 lot# 336700, mlry-hd 15x180 stem por lat catalog# 11-104215 lot# 355520, m2a-magnum 52-60mm tpr ins std catalog# 139268 lot# 676820.No device was returned, therefore, no visual or dimensional inspections were conducted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-00515, 0001825034-2017-06514, 0001825034-2017-06515.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The revision surgery is confirmed.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: M2A MAGNUM MODULAR HEAD 52MM HEAD DIAMETER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6315832
• MDR Text Key: 67089477
• Report Number: 0001825034-2017-00515
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 157452
• Device Lot Number: 884940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR