MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 32MM +3 HIWALL LNR SZ22; PROSTHESIS, HIP

Model Number N/A

Device Problems Detachment Of Device Component (1104); Degraded (1153); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); No Code Available (3191)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent a right total hip arthroplasty on (b)(6) 2013.Subsequently, patient's legal counsel reported patient was revised on (b)(6) 2014 due to patient allegations of pain, bone/tissue damage, loss of range of motion, elevated metal ion levels and metallosis.Review of invoice history revealed that the patient was implanted with a metal on polyethylene hip on (b)(6) 2013.Invoice history confirms the modular head and polyethylene liner were removed and replaced during the revision surgery.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.Additional information received in the patient¿s right hip operative reports noted patient underwent a revision on (b)(6) 2014 due to pain and x-rays indicating dissociation of the acetabular liner.Operative report noted the presence of dark fluid with metallosis debris, a disassociated liner, and a wear of the locking ring.The modular head, acetabular liner and locking ring were removed and replaced.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "wear and/or deformation of articulating surfaces." and "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." 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 1825034-2014-06787 & 2015-00615).

• Brand Name: E-POLY 32MM +3 HIWALL LNR SZ22
• 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: 4534325
• MDR Text Key: 16174258
• Report Number: 0001825034-2015-00615
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090103
• 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: 02/13/2015

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-108322
• Device Lot Number: 826070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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: 61 YR