MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR INTEGRAL CENTRALIZER 11MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Complaint, Ill-Defined (2331); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/04/2011

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent left total hip arthroplasty on (b)(6) 2006 and a right total hip arthroplasty on (b)(6) 2007.Legal counsel for patient further reported patient underwent a right hip revision procedure on (b)(6) 2011 and a left hip arthroplasty on (b)(6) 2014 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, metal poisoning, elevated metal ion levels and metallosis.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 6 states, ¿inadequate range of motion due to improper selection or positioning of components.¿ number 14 states, ¿postoperative bone fracture and pain.¿ this report is number 4 of 4 mdrs filed for the same event (reference 1825034-2014-04967 / 04970).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.

Event Description

Legal counsel for patient reported patient underwent left total hip arthroplasty on (b)(6) 2006 and a right total hip arthroplasty on (b)(6) 2007.Legal counsel for patient further reported patient underwent a right hip revision procedure on (b)(6) 2011 and a left hip arthroplasty on (b)(6) 2014 due to patient allegations of pain, swelling, inflammation, damage to surrounding bone and tissue, lack of mobility, loss of range of motion, metal poisoning, elevated metal ion levels and metallosis.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.Additional information received in patient medical records revealed left hip revision on (b)(6) 2014 was due to a loose stem.The patient's operative report noted brownish fluid and the loose stem.The head, stem and taper adapter were removed and replaced.Additional information received in patient medical records revealed the right hip revision on (b)(6) 2011 was due to pain, fracture of the cement mantle, and possible metallosis.The patient's operative report noted reactive tissue consistent with metallosis, and the loose stem.The head, stem and taper adapter were removed and replaced.

• Brand Name: COCR INTEGRAL CENTRALIZER 11MM
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3839010
• MDR Text Key: 19725191
• Report Number: 0001825034-2014-04970
• 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,Followup
• Report Date: 11/07/2014

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: 11/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 12-162611
• Device Lot Number: 761320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 05/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2006
• 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: 74 YR