MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 36MM COCR MODULAR HEAD STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Tissue Damage (2104); Discomfort (2330); Toxicity (2333); Osteolysis (2377); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/03/2014

Event Type  Injury  

Event Description

Legal counsel for patient reported that patient underwent left hip arthroplasty on (b)(6) 2005.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2014 due to patient allegations of pain, swelling, inflammation, bone/tissue damage, discomfort, soreness, loss of range of motion, metallosis, metal poisoning and elevated metal ion levels.A review of invoice history revealed that the procedure in 2005 was a revision procedure to replace the modular head on (b)(6) 2005 due to an unknown reason.Invoice history also confirmed that the modular head was removed and replaced during a revision procedure on (b)(6) 2014.The date of the original total hip arthroplasty is unknown.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: "material sensitivity reactions." and "inadequate range of motion due to improper selection or positioning of components." and "postoperative bone fracture and pain." this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

• Brand Name: 36MM COCR MODULAR HEAD 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: 4038362
• MDR Text Key: 18792383
• Report Number: 0001825034-2014-07332
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032396
• 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: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-363662
• Device Lot Number: 588880
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2004
• 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