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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Necrosis (1971); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 11/11/2014

Event Type  Injury  

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 15 states, "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 2 mdrs filed for the same event (reference 1825034-2015-05191 / 05198).

Event Description

It was reported by the patient's legal counsel that the patient underwent an initial right hip arthroplasty on (b)(6) 2005.Subsequently, the patient was revised on (b)(4) 2014 due to alleged elevated metal ion levels, tissue abnormalities, and pseudotumor.Operative report noted metal stained tissue, necrosis, pseudotumors, well-fixed cup and stem, bone loss around the cup, greater trochanter, pubis and ischium during the procedure.The head, cup, and liner were removed and replaced with a biomet head and competitor cup and liner.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• 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: 5332079
• MDR Text Key: 34581886
• Report Number: 0001825034-2015-05198
• 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
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 15-105004
• Device Lot Number: 212820
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2004
• 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: 77 YR