MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A-MAGNUM 42-50 TPR INSRT STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Inflammation (1932); Damage to Ligament(s) (1952); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Test Result (2695)

Event Date 04/19/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent left total hip arthroplasty on (b)(6) 2005.Patient's legal counsel reported patient was revised on (b)(6) 2013 due to patient allegations of pain, loss of range of motion, bone/tissue damage, elevated metal ion levels and metallosis.The modular head, acetabular cup 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.Operative report received noted patient underwent a left hip revision on (b)(6) 2013 due to pain and elevated metal ion levels.Operative report noted the presence of straw-colored joint fluid, stained soft tissue, a fractured greater trochanter during removal of the taper adapter, discolored trunnion, and granulomatous cyst with metallic stained debris.The modular head, taper adapter and acetabular cup were removed and replaced.Operative report noted patient underwent a right total hip arthroplasty on (b)(6) 2005 and a right hip revision procedure on (b)(6) 2014.Revision operative report received noted the revision was due to pain and elevated metal ion levels.Operative report noted the presence of milky colored fluid, tissue stained with metallic debris, synovitis, and corrosion on the trunnion.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: "intraoperative or postoperative bone fracture and/or postoperative pain." and "fretting and crevice corrosion may occur at interfaces between components." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 3 of 5 mdrs filed for the same patient (reference 1825034-2014-05491 /-05492 /-07018 /-07019 /-07020).

• Brand Name: M2A-MAGNUM 42-50 TPR INSRT STD
• 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: 4004341
• MDR Text Key: 4959209
• Report Number: 0001825034-2014-07018
• 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: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 684790
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2005
• 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: 64 YR