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

Model Number N/A

Device Problems Device Slipped (1584); Metal Shedding Debris (1804); Failure to Osseointegrate (1863); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Purulent Discharge (1812); Pain (1994); Scar Tissue (2060); Toxicity (2333); Osteolysis (2377); Reaction (2414); Inadequate Osseointegration (2646); Test Result (2695); Fibrosis (3167)

Event Date 11/01/2006

Event Type  Injury  

Event Description

Legal counsel for patient reported that the patient had an initial right hip arthroplasty on (b)(6) 2004.Subsequently, the patient was revised on (b)(6) 2006 due to patient allegations of pain, and clicking/popping.The patient¿s operative report noted fibrotic tissue, metallosis debris, purulent appearing yellow fluid, and an anterverted cup.The head and cup were removed and replaced.The patient underwent further revision on (b)(6) 2006 due to dislocations.The patient¿s operative report noted scar tissue, bone osteophytes, and a loose cup with minimal in-growth.The head and cup were removed and replaced with a biomet head and a competitor cup.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 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 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is number 1 of 4 mdrs filed for the same patient (reference 1825034-2015-00182 / 00185).

• Brand Name: M2A 38MM MOD HD STD NK
• 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: 4414884
• MDR Text Key: 5276393
• Report Number: 0001825034-2015-00182
• Device Sequence Number: 1
• Product Code: JDI
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 11-173662
• Device Lot Number: 384200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2006
• 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: 32 YR