MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-TAPER LINER SZ 41/32; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Disability (2371); Ambulation Difficulties (2544)

Event Date 10/01/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2003.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, dysfunction, lack of mobility, loss of range of motion, metallosis and elevated metal ion levels.A review of invoice history confirmed both surgery dates and suggests that the acetabular cup, taper liner and modular head were removed and replaced with competitor acetabular components and a biomet modular head.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.There are warnings in the package insert that state that this type of event can occur: "material sensitivity reactions." and "inadequate range of motion due to improper selection or positioning of components." and "intraoperative or postoperative bone fracture and/or postoperative pain." and "elevated metal ion levels have been reported with metal on metal articulating surfaces." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 3 mdrs filed for the same event (reference 1825034-2014-06560 / 06562).

Manufacturer Narrative

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

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty on (b)(6) 2003.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, dysfunction, lack of mobility, loss of range of motion, metallosis and elevated metal ion levels.A review of invoice history confirmed both surgery dates and suggests that the acetabular cup, taper liner and modular head were removed and replaced with competitor acetabular components and a biomet modular head.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received from patient operative report notes metal reaction inside the hip joint, necrosis of the joint lining with both white and gray discolored tissue, and corrosion between the femoral head and stem.

• Brand Name: M2A-TAPER LINER SZ 41/32
• 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: 3966333
• MDR Text Key: 15178420
• Report Number: 0001825034-2014-06561
• 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: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2013
• Device Model Number: N/A
• Device Catalogue Number: 15-105004
• Device Lot Number: 155280
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2003
• 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: 49 YR