MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 32MM M2A MOD HEAD -6MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Disability (2371); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Legal counsel for the patient alleges that patient underwent a right total hip arthroplasty on (b)(6) 2003 and a left total hip arthroplasty on (b)(6) 2003.Subsequently, legal counsel for patient alleges patient underwent a revision procedure of the right hip on (b)(6) 2012 and the left hip on (b)(6) 2004, due to patient allegations of pain, discomfort, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility and range of motion, soreness, dysfunction, and metal poisoning and metallosis.Patient¿s legal counsel reports patient underwent a second right hip revision on (b)(6) 2013 due to allegations of infection.A review of invoice history confirmed the initial surgery dates for both hips and the left hip revision procedure on (b)(6) 2004; however, invoice history for both right hip revisions could not be located and it is unknown which components were removed and/or 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 2 states, "early or late postoperative infection and allergic reaction." 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.¿ number 15 states, ¿elevated metal ion levels have been reported.¿ review of sterilization certification confirms device was sterilized in accordance with (b)(4).Date explanted - unknown.The right hip was revised on (b)(6) 2012 & (b)(6) 2003 and the component could have been removed during either procedure.However, invoice history could not be located for the revision dates mentioned.This report is number 2 of 5 mdrs filed for the same event (reference (reference 1825034-2014-01967, -01970, -01972 / -01974).

• Brand Name: 32MM M2A MOD HEAD -6MM NK
• 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: 3692677
• MDR Text Key: 20638228
• Report Number: 0001825034-2014-01970
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• 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: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2011
• Device Model Number: N/A
• Device Catalogue Number: 11-163667
• Device Lot Number: 816120
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2001
• 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