MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SELEX/MAGNUM MOD HD 40MM -6; PROSTHESIS, HIP

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Edema (1820); Toxicity (2333)

Event Date 04/01/2011

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent a total hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reports a revision procedure was performed on (b)(6) 2011 due to elevated metal ion levels and metal debris within the joint.Operative report notes the presence of fluid and wear on the neck of the femoral stem.The modular head was removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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.There are warnings in the package insert that state that this type of event can occur: "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-01583 & 01584).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

Legal counsel for patient reported that patient underwent a right total hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reports a revision procedure was performed on (b)(6) 2011 due to elevated metal ion levels and metal debris within the joint.Operative report notes the presence of fluid and wear on the neck of the femoral stem.The modular head was removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: SELEX/MAGNUM MOD HD 40MM -6
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4707515
• MDR Text Key: 18026068
• Report Number: 0001825034-2015-01584
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: S061140
• Device Lot Number: 097930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2006
• 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: 61 YR