MAUDE Adverse Event Report: BIOMET ORTHOPEDICS E-POLY 36MM +3 HIWALL LINER SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 12/11/2013

Event Type  Injury  

Event Description

It was reported that patient underwent total right hip arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2013 and (b)(6) 2014 due to dislocation.Polyethylene liner and modular head components were removed and replaced in both procedures.Currently, patient reports to be experiencing pain, clicking, popping, and instability.

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 8 states, ¿dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity." number 14 states "intraoperative and postoperative bone fracture and/or postoperative pain" this report is number 2 of 5 mdrs filed for the same event (reference 1825034-2014-02664 / 02668).

• Brand Name: E-POLY 36MM +3 HIWALL LINER SZ23
• 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: 3741685
• MDR Text Key: 4274637
• Report Number: 0001825034-2014-02665
• Device Sequence Number: 1
• Product Code: MAY
• 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: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 599310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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: 63 YR