BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD STD NK

    MDR report key: 3970565 · Received July 31, 2014

    Report

    Report Number
    0001825034-2014-06668
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    April 11, 2006
    Report Date
    October 31, 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION THAT 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 WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." CORRECTION: DEVICE PRODUCT CODE HAS BEEN CORRECTED IN THIS REPORT.

    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. BRAND NAME - UNKNOWN. EXPIRATION DATE - UNKNOWN. 510K NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. 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 RIGHT 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 A REVISION PROCEDURE ON (B)(6), 2006. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATES 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 RIGHT 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 A REVISION PROCEDURE ON (B)(6) 2006. AN INVOICE HISTORY COULD NOT BE LOCATED TO CONFIRM THE SURGERY DATES 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. ADDITIONAL INFORMATION RECEIVED IN PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT WAS REVISED DUE TO INSTABILITY. REVISION OP REPORT NOTES SCARRED, INFLAMED HIP CAPSULE. THE MODULAR HEAD, LINER, AND SHELL WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448922 28MM DIA COCR MOD HD STD NK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 215250

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R