MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM MODULAR HEAD 42MM HEAD DIAMETER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 3 of 3 mdrs filed for the same patient (reference 1825034-2016-05074 / 05075 / 05076).

Event Description

It was reported patient underwent a hip revision approximately eight years post-implantation due to taper being stuck to stem.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: M2A MAGNUM MODULAR HEAD 42MM 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: 6150900
• MDR Text Key: 61615919
• Report Number: 0001825034-2016-05076
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 157442
• Device Lot Number: 532210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR