MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR INTEGRAL CENTRALIZER 13MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Granuloma (1876); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Tissue Damage (2104); Toxicity (2333); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/04/2008

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a left total hip arthroplasty on (b)(6) 2002.Patient's legal counsel further reported patient allegations of pain, lack of mobility, damage to bone/tissue, metal poisoning, metallosis and elevated metal ion levels.Subsequently, patient underwent revision procedures on (b)(6) 2007 and (b)(6) 2008.A review of the invoice history indicates patient underwent a total hip arthroplasty on (b)(6) 2007.Invoice history further suggests patient underwent a revision procedure on (b)(6) 2008 due to infection.A revision invoice could not be located to confirm the december 27, 2007.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 arthroplasty on (b)(6) 2007 and a left hip arthroplasty on (b)(6) 2002.Revision operative report noted patient underwent a left hip revision on (b)(6) 2008 due to infection.Operative report further noted the presence of serous drainage, granulation tissue, synovitis and a greater trochanteric fracture during removal of the stem.All components were removed and replaced with cement spacers.Operative report noted patient underwent an additional left hip revision on (b)(6) 2008 due to a femur fracture and loose femoral spacers.The femoral cement spacers were removed and competitor components were implanted.No revision was reported for the right hip.

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 "early or late postoperative infection and allergic reaction." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 5 of 5 mdrs filed for the same patient (reference 1825034-2014-06054/6057 & 2015-01105).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

• Brand Name: COCR INTEGRAL CENTRALIZER 13MM
• 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: 4621589
• MDR Text Key: 5761424
• Report Number: 0001825034-2015-01105
• 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: 03/03/2015

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: Biomedical Engineer
• Device Expiration Date: 07/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 12-162613
• Device Lot Number: 795600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2002
• 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: 57 YR