MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FREEDOM STD FACE LINER SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/05/2015

Event Type  Injury  

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 2 states, ¿early or late postoperative, infection, and allergic reaction.¿ 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 3 mdrs filed for the same event (reference 1825034-2015-03689 / 03690 / 03691).

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2004.Patient's legal counsel further reports that a revision procedure took place on (b)(6) 2015 due to patient allegations of infection and a pseudotumor.The patient was alleged to have received temporary prosthetics during the revision procedure.Review of invoice history confirmed the initial surgery date and that a revision procedure occurred on (b)(6) 2015.The modular head was removed and replaced with a constrained head and acetabular liner during the revision procedure.This report is based on allegations set forth in plaintiffcomplaint and the allegations contained therein are unverified.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 2 of 4 mdrs filed for the same event (reference 1825034-2015-03689 / 2015-03690 / 2015-03691 / 2016-01088).Not returned by attorney.

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2004.Patient's legal counsel further reports that a revision procedure took place on (b)(6) 2015 due to patient allegations of infection and a pseudotumor.The patient was alleged to have received temporary prosthetics during the revision procedure.Review of invoice history confirmed the initial surgery date and that a revision procedure occurred on (b)(6) 2015.The modular head was removed and replaced with a constrained head and acetabular liner during the revision procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received reported metal on metal wear as an additional reason for revision.It was further reported that patient underwent a reimplantation procedure on (b)(6) 2015.The procedure was completed with competitor product.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

Legal counsel for patient reported that patient underwent left total hip arthroplasty on (b)(6) 2004.Patient's legal counsel further reports that a revision procedure took place on (b)(6) 2015 due to patient allegations of infection and a pseudotumor.The patient was alleged to have received temporary prosthetics during the revision procedure.Review of invoice history confirmed the initial surgery date and that a revision procedure occurred on (b)(6) 2015.The modular head was removed and replaced with a constrained head and acetabular liner during the revision procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received reported metal on metal wear as an additional reason for revision.It was further reported that patient underwent a reimplantation procedure on (b)(6) 2015.The procedure was completed with competitor product.Operative report received for (b)(6) 2015 revision procedure noted osteolysis, loosening of the acetabular component, infection and the removal of a pseudotumor.During the procedure, all components were removed and replaced.A competitor stem was used, and the constrained liner was cemented directly into the patient's acetabulum.

• Brand Name: FREEDOM STD FACE LINER SZ 24
• 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: 5019104
• MDR Text Key: 23627625
• Report Number: 0001825034-2015-03690
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Followup,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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: 11-107323
• Device Lot Number: 970570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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: 70 YR