MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BIOMET METAL-ON-METAL HIP SYSTEMS; HIP PROSTHESIS

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); Device Embedded In Tissue or Plaque (3165)

Event Date 01/07/2010

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Event Description

Legal counsel for patient reported that patient underwent a left total hip revision procedure approximately seven years post-implantation due to alleged corrosion, friction wear, metal debris, pain, limited mobility, and elevated metal ion levels.The cup and head were removed and replaced and a liner was implanted.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

• Brand Name: BIOMET METAL-ON-METAL HIP SYSTEMS
• Type of Device: HIP PROSTHESIS
• 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: 6412975
• MDR Text Key: 70250487
• Report Number: 0001825034-2017-00780
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-163670
• Device Lot Number: 180950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2003
• 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: 69 YR