MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC POR LAT FMRL 9X137; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333); Disability (2371)

Event Date 01/07/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent total bilateral hip arthroplasties on (b)(6) 2009.Patient's legal counsel further reported that a left hip revision procedure was performed on (b)(6) 2014 due to patient allegations of pain, disability and metallosis.No right hip revision procedure has been reported to date.A review of invoice history confirmed both surgery dates and that the modular head and taper adaptor were removed and replaced.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

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 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is number 7 of 8 mdr's filed for the same event (reference 1825034-2014-01572 / 01573 & 01717 / 01723).

• Brand Name: TAPERLOC POR LAT FMRL 9X137
• 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: 3677999
• MDR Text Key: 4240328
• Report Number: 0001825034-2014-01721
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• 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: 02/11/2014

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: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-103203
• Device Lot Number: 409950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2009
• 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