MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM 52-60MM TPR INSRT-6; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Defective Component (2292); Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 07/22/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported that the patient underwent right total hip arthroplasty on (b)(6) 2006.Legal counsel further reported that the patient was revised on (b)(6) 2014 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue and lack of mobility.The modular head and taper adapter were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the operative report noted patient underwent a right hip revision on (b)(6) 2014 due to pain, wear, elevated metal ion levels and periprosthetic osteolysis.Operative report noted the presence of greyish synovial fluid, capsule synovitis with joint effusion, capsular and periprosthetic tissue metallosis with black stained tissue, pseudotumor, osteolytic debris, metal stained lesion, wear debris, wear and trunnion corrosion, and a cavitary defect in the acetabulum.The stem and acetabular cup were noted to be well fixed.The modular head and taper adapter were removed and replaced.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "fretting and crevice corrosion may occur at interfaces between components," "material sensitivity reactions.It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant," "wear and/or deformation of articulating surfaces," "intraoperative or postoperative bone fracture and/or postoperative pain," and "elevated metal ion levels have been reported with metal on metal articulating surfaces." 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 patient (reference 1825034-2014-08549 & 2015-01439).

• Brand Name: M2A-MAGNUM 52-60MM TPR INSRT-6
• 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: 4670102
• MDR Text Key: 20071317
• Report Number: 0001825034-2015-01439
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• 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: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 139264
• Device Lot Number: 818930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2005
• 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: 37 YR