MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TAPER LINER 32MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2017-00286 & 00297).

Event Description

Patient underwent a hip revision procedure approximately 15 years post-implantation due to elevated metal ion levels.The modular head, taper liner, and acetabular cup were revised.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.

• Brand Name: M2A TAPER LINER 32MM
• 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: 6282885
• MDR Text Key: 65942859
• Report Number: 0001825034-2017-00297
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/20/2011
• Device Model Number: N/A
• Device Catalogue Number: 15-105004
• Device Lot Number: 017910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2001
• 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: 71 YR