MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A TPR HI CARBON 41/32MM LINER; 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); Ambulation Difficulties (2544)

Event Date 09/13/2012

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent right total hip arthroplasty in (b)(6) 2007.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, lack of mobility, loss of range of motion, metal poisoning, metallosis and elevated metal ion levels.A review of invoice history indicates the initial hip surgery was performed on (b)(6) 2007.Invoice history confirmed the date of the revision surgery and that the acetabular cup and modular head were 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: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿postoperative bone fracture and pain.¿ number 15 states, ¿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 1825034-2014-05699 / 05700).

Manufacturer Narrative

The 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 in (b)(6) 2007.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2012 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, metal poisoning, metallosis and elevated metal ion levels.A review of invoice history indicates the initial hip surgery was performed on (b)(6) 2007.Invoice history confirmed the date of the revision surgery and that the acetabular cup and modular head were removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Operative report received noted patient underwent a right hip revision on (b)(6) 2012 due to pain and a soft mass.Revision operative report noted the presence of metal staining, fluid, synovitis, turbid yellow material, and patulous stretched capsular tissue.The acetabular cup, taper liner and modular head were removed and replaced.

• Brand Name: M2A TPR HI CARBON 41/32MM LINER
• 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: 3895596
• MDR Text Key: 15358761
• Report Number: 0001825034-2014-05700
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 040480
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2007
• 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: 48 YR