MAUDE Adverse Event Report: BIOMET ORTHOPEDICS THE ANSWER COCR HIP 13MMX145MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 10/28/2010

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent right total hip arthroplasty on (b)(6) 2010 and a revision procedure on (b)(6) 2010 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, metal poisoning, metallosis and elevated metal ion levels.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 right hip revision in (b)(6) 2010 due to a leg length discrepancy.Operative report noted the presence of an effusion, a previous posterior repair had failed and the femur fractured during removal of the stem.All components 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 " undesirable shortening of limb." 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 3 mdrs filed for the same event (reference 1825034-2014-05310 /-05311 /-06791).

• Brand Name: THE ANSWER COCR HIP 13MMX145MM
• 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: 3978047
• MDR Text Key: 4637781
• Report Number: 0001825034-2014-06791
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK931194
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 162603
• Device Lot Number: 416450
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2007
• 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: 76 YR