MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FREEDOM STD FACE LINER SZ 27; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Coagulation Disorder (1779); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scarring (2061); Swelling (2091); Discomfort (2330); Toxicity (2333); Deformity/ Disfigurement (2360); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 03/27/2013

Event Type  Injury  

Event Description

It was reported that the patient had an initial left hip arthroplasty on (b)(6) 2002 with competitor product.The patient reported a fall, causing a femur fracture in 2010 at which time an open reduction internal fixation (orif) was performed with an unknown plate.The patient was then revised to a magnum on (b)(6) 2011 due to aseptic loosening of acetabulum and femur.Legal counsel for the patient reported patient allegations of pain, swelling, inflammation, discomfort, soreness, dysfunction, loss of range of motion, metallosis, leg length inequality, metal poisoning, lack of mobility, and elevated metal ion levels.Subsequently, patient underwent an irrigation and debridement on (b)(6) 2011 and was revised to a spacer mold on (b)(6) 2011.The patient was revised to a freedom head and liner with spacers due to infection on (b)(6) 2011, which was noted as the first stage of a two stage revision.The patient reportedly underwent multiple irrigation & debridements in 2012.Finally, it was reported that the second stage of the revision occurred on (b)(6) 2013 when patient received an arcos hip.Operative (op) notes dated (b)(6) 2011 reports the presence of serosanguineous fluid, necrotic and purulent subcutaneous tissue, subcutaneous abscesses, and granulation layer with granulation tissue.Op report dated (b)(6) 2011 notes granulation tissue and that the hip would not dislocate.Pus and devitalized tissue were noted in an op report dated (b)(6) 2011.Finally, op report dated (b)(6) 2013 notes segmental bone loss, proximal diaphysis femur fracture with hypertrophic nonunion, fibroinflammatory debris, hypertrophic scar tissue, leg length inequality of 7 cm short on the left side, and the need for intraoperative coagulopathy that required blood factor support during the procedure.

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, it states, ¿material sensitivity reactions.¿ ¿inadequate range of motion due to improper selection or positioning of components.¿, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ ¿elevated metal ion levels have been reported with metal-on-metal articulating surfaces.¿ "loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." ¿intraoperative bone perforation or fracture may occur.¿ ¿undesirable shortening of limb.¿ ¿fatigue fracture of component may occur.¿ this report is number 4 of 5 mdrs filed for the same event (reference 1825034-2014-08741/ -08745).

• Brand Name: FREEDOM STD FACE LINER SZ 27
• 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: 4270948
• MDR Text Key: 5004005
• Report Number: 0001825034-2014-08745
• 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: Initial
• Report Date: 11/04/2014

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: 01/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-107326
• Device Lot Number: 183500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2011
• 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: 66 YR