MAUDE Adverse Event Report: BIOMET ORTHOPEDICS INTEGRAL/X POR STANDARD 9MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Injury (2348); Disability (2371); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Patient's legal counsel reported that patient underwent total hip arthroplasty and further reports patient allegations of personal injuries.A review of invoice history confirmed the primary surgery date was (b)(6) 2006.There has been no reported revision procedure.This report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.Additional information received from patient's legal counsel reports that patient underwent total hip arthroplasty and further reports patient allegations of pain, inflammation, dysfunction, loss of range of motion, metal poisoning, metallosis, lack of mobility, swelling, damage to surrounding bone and tissue and elevated metal ion levels.No revision procedure has been reported.

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: "material sensitivity reactions.¿ and "intraoperative or postoperative bone fracture and/or postoperative pain." and "inadequate range of motion due to improper selection or positioning of components." and "elevated metal ion levels have been reported with metal-on-metal articulating surfaces." this report is based on allegations set forth in patient¿s complaint and the allegations contained therein are unverified.This report is number 3 of 4 mdrs filed for the same event (reference 18250342012-02544 & 2014-01881/-01882/-01883).

• Brand Name: INTEGRAL/X POR STANDARD 9MM
• 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: 3688789
• MDR Text Key: 17924447
• Report Number: 0001825034-2014-01882
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030501
• 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: 02/24/2014

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: 02/29/2016
• Device Model Number: N/A
• Device Catalogue Number: X170309
• Device Lot Number: 697460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2009
• 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