MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A 38MM MOD HD +12MM NK SKRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Toxicity (2333); Reaction (2414); Fluid Discharge (2686); Test Result (2695)

Event Date 10/27/2014

Event Type  Injury  

Event Description

Patient's legal counsel reported that the patient underwent an initial right hip arthroplasty on (b)(6) 2008.Subsequently, the patient was revised on (b)(6) 2014 due to metallosis and elevated metal ion levels.Revision operative report noted the presence of thickened inflamed trochanteric bursa, cloudy synovial fluid with floating debris, abnormal fluid, gray unhealthy-appearing pseudocapsular tissue, corrosion and oxides at the trunnion, and partial fracturing of the rim of bone around the cup.The modular head and acetabular cup were removed and replaced this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

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 "material sensitivity reactions." 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 1 of 2 mdrs filed for the same event (reference 1825034-2015-01662 /-01663).

• Brand Name: M2A 38MM MOD HD +12MM NK SKRT
• 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: 4715535
• MDR Text Key: 19496297
• Report Number: 0001825034-2015-01662
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• 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: 03/27/2015

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: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-173666
• Device Lot Number: 572520
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2008
• 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