MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RECAP CEMENT FMRL HEAD RESUR 50M; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)

Event Date 09/05/2013

Event Type  Injury  

Event Description

Legal counsel for patient reports patient underwent a total hip arthroplasty on (b)(6) 2011.Patient's legal counsel further reported that a revision procedure was performed due to patient allegations of pain, swelling, inflammation, damage to bone and tissue and loss of mobility.The date of the revision procedure was not provided.A review of invoice history could not confirm the surgery dates.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in patient¿s medical record indicates patient underwent a left femoral resurfacing procedure (b)(6) 2011.Records further indicate patient was revised (b)(6) 2013 due to pain.Revision operative notes report the presence of effusion with clear fluid within the joint and a loose acetabular component with metal staining of fibrous membrane within the acetabulum.The cup and head were removed and replaced with competitor components.

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 ¿loosening or migration of the 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 1825034-2014-02291 and -06442).

• Brand Name: RECAP CEMENT FMRL HEAD RESUR 50M
• 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: 3957204
• MDR Text Key: 4609416
• Report Number: 0001825034-2014-06442
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK021799
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: US157250
• Device Lot Number: 022060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2007
• 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: 41 YR