MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR INTEGRAL CENTRALIZER 9MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Tissue Damage (2104); Toxicity (2333); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/16/2013

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a right metal-on-metal hip arthroplasty on (b)(6) 2006.Patient's legal counsel further reported that a revision procedure was performed on (b)(6) 2013 due to patient allegations of pain, lack of mobility, damage to bone/tissue, metal poisoning, metallosis and elevated metal ion levels.A review of the invoice history confirmed the initial surgery date; however, it indicates patient was not implanted with metal-on-metal components.The invoice history further indicates patient underwent a revision procedure on (b)(6) 2013 where all components were removed and replaced.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.Additional information received in the operative report noted patient underwent a right hip revision on (b)(6) 2013 due to aseptic femoral loosening.Operative report further noted the presence of wear on the liner.The modular head, stem and liner 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: "loosening or migration of implants may occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." 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 mdr's filed for the same patient (reference 1825034-2014-05342 and 2015-01200 /-01201).

• Brand Name: COCR INTEGRAL CENTRALIZER 9MM
• 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: 4629970
• MDR Text Key: 5754618
• Report Number: 0001825034-2015-01201
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK942479
• 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: 03/06/2015

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: 08/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 12-162609
• Device Lot Number: 010800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2004
• 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
• Patient Age: 68 YR