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

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Toxicity (2333)

Event Date 04/15/2002

Event Type  Injury  

Event Description

Legal counsel for patient reported patient underwent a total hip arthroplasty on (b)(6) 2000.Subsequently, patient's legal counsel reports patient allegations of pain, bone/tissue damage, lack of mobility, loosening and metallosis.Review of invoice history indicates patient underwent a revision procedure on (b)(6) 2002.The modular head and femoral stem was removed and replaced.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 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ 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 based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-06538 / 06539).

Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.This report is number 2 of 4 mdrs filed for the same patient (reference 1825034-2014-06538 /-06539 & 2015-01103 /-01104).

Event Description

Legal counsel for patient reported patient underwent a total hip arthroplasty on (b)(6) 2000.Subsequently, patient's legal counsel reports patient allegations of pain, bone/tissue damage, lack of mobility, loosening and metallosis.Review of invoice history indicates patient underwent a revision procedure on (b)(6) 2002.The modular head and femoral stem was 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 procedure on (b)(6) 2002 due to loosening.Revision operative report noted the presence of fibrous tissue with granulomatous disease and a loose stem.The modular head and stem were removed and replaced.Operative report further noted patient underwent an additional right hip revision on (b)(6) 2002 due to dislocation.Operative report noted the presence of an osteophyte and nonunion of a fractured greater trochanter.The modular head, liner and acetabular cup 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 3964991
• MDR Text Key: 4622136
• Report Number: 0001825034-2014-06539
• 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: Physician
• Device Expiration Date: 02/28/2010
• Device Model Number: N/A
• Device Catalogue Number: 12-162611
• Device Lot Number: 256180
• 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: 07/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2000
• 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: 66 YR