MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC MICROP FMRL 9.0MM; 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); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

Legal counsel for the patient alleges that patient underwent m2a hip arthroplasty on (b)(6) 2008.Subsequently, patient was revised on (b)(6) 2008, for an unknown reason.This report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.Additional information received from patient's legal counsel reports that patient underwent a right total hip arthroplasty on (b)(6) 2008 and a left total hip arthroplasty on (b)(6) 2008.Subsequently, patient had a right hip revision on (b)(6) 2008 and again on (b)(6) 2013 due to patient allegations of pain, swelling, inflammation, and damage to surrounding bone and tissue, and lack of mobility, loss of range of motion, elevated metal ion levels, and dysfunction.Lawsuit alleges the presence of fluid during the right hip revision procedure.No left revision has been reported.

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: "material sensitivity reactions.¿ and "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 6 of 9 mdrs filed for the same event (reference 1825034-2012-01658 & 2014-01701/-01708).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: 2.Early or late postoperative infection and allergic reaction.This report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.

Event Description

Legal counsel for the patient alleges that patient underwent m2a hip arthroplasty on (b)(6) 2008.Subsequently, patient was revised on (b)(6) 2008, for an unknown reason.Additional information received from patient's legal counsel reports that patient underwent a right total hip arthroplasty on (b)(6) 2008 and a left total hip arthroplasty on (b)(6) 2008.Subsequently, patient had a right hip revision on (b)(6) 2008 and again on (b)(6) 2013 due to patient allegations of pain, swelling, inflammation, and damage to surrounding bone and tissue, and lack of mobility, loss of range of motion, elevated metal ion levels, and dysfunction.Lawsuit alleges the presence of fluid during the right hip revision procedure.No left revision has been reported.Additional information provided in patient medical records indicates the right hip revision performed on (b)(6) 2008 was due to infection.The patient's operative report noted purulent fluid and purulent material, loose cup, and granulating tissue.Additional information provided in patient medical records indicates the right hip revision performed on (b)(6) 2013 was due to pain.The patient's operative report noted fluid, scar tissue, inflammation, and heterotopic ossification.This report is based on allegations set forth in patient's complaint and the allegations contained therein are unverified.

• Brand Name: TAPERLOC MICROP FMRL 9.0MM
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3678879
• MDR Text Key: 4243454
• Report Number: 0001825034-2014-01705
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050441
• 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: 03/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 14-103203
• Device Lot Number: 792410
• 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: 05/03/2007
• 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