MAUDE Adverse Event Report: BIOMET ORTHOPEDICS CER OPTION TYPE 1 TPR SLEVE +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 12/10/2015

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.The following sections could not be completed with the limited information provided; initial reporter.Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and allergic reaction." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 3 of 4 mdr's filed for the same event (reference 1825034-2015-05160 / 05161 / 05162 / 05163).

Event Description

It was reported by the patient's legal counsel that patient underwent right total hip arthroplasty on (b)(6) 2011.Subsequently, patient underwent a tendon release procedure on (b)(6) 2014 due to chronic tendonitis.Patient was then revised on (b)(6) 2014 due to pain secondary to bursitis of the greater trochanter and chronic tendonitis.During the procedure the femoral head was removed and replaced with an active articulation liner and head.Patient then underwent another revision on (b)(6) 2014 due to infection.During the procedure the stem, cup, and head were removed and replaced with a spacer mold.On (b)(6) 2015 the spacer molds were removed and replaced with a stem, acetabular cup, and an active articulation liner and head.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +3
• 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: 5331796
• MDR Text Key: 34568169
• Report Number: 0001825034-2015-05162
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082996
• 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 Model Number: N/A
• Device Catalogue Number: 650-1067
• Device Lot Number: 749530
• 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: 07/04/2014
• 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: 71 YR