BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -6MM NECK

    MDR report key: 3970543 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06664
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 3, 2014
    Report Date
    October 28, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. (B)(4). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CORRECTION: DEVICE PRODUCT CODE HAS BEEN CORRECTED IN THIS REPORT. DATE OF IMPLANT HAS BEEN CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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 CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY.¿ 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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06664 / -08525). THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06664 AND 08525).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. 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 A REVISION PROCEDURE ON (B)(6) 2014. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE REVISION PROCEDURE; HOWEVER, AN INITIAL INVOICE COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATE AND WHICH COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. 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 A REVISION PROCEDURE ON (B)(6) 2014. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE REVISION PROCEDURE; HOWEVER, RECORDS SHOW THE ACTUAL IMPLANT DATE WAS (B)(6) 2011. THE HEAD AND STEM WERE REMOVED AND REPLACED DURING THE (B)(6) 2014 REVISION PROCEDURE.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. 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 A REVISION PROCEDURE ON (B)(6) 2014. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A REVIEW OF THE INVOICE HISTORY CONFIRMED THE REVISION PROCEDURE; HOWEVER, RECORDS SHOW THE ACTUAL IMPLANT DATE WAS (B)(6) 2011. THE HEAD AND STEM WERE REMOVED AND REPLACED DURING THE (B)(6) 2014 REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS REVEALED THE (B)(6) 2014 REVISION PROCEDURE WAS DUE TO A PROTRUDING FEMORAL COMPONENT. THE PATIENT'S OPERATIVE REPORT NOTED THE FEMORAL COMPONENT WAS PROTRUDING OUT OF THE LATERAL ANTEROLATERAL CORTEX OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447697 32MM MOD HEAD COCR -6MM NECK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 746080

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R