BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD 2HL SHL 41/56MM

    MDR report key: 3112445 · Received May 14, 2013

    Report

    Report Number
    0001825034-2013-01499
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    March 13, 2012
    Report Date
    July 11, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT IDENTIFICATION & EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE AND/OR PRODUCT IDENTIFICATION, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    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. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE 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 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01499 & 05146 / 05148).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, LEGAL COUNSEL FOR THE PATIENT ALLEGES A REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF METALLOSIS. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO PAIN AND INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6)2005. SUBSEQUENTLY, LEGAL COUNSEL FOR THE PATIENT ALLEGES A REVISION WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF METALLOSIS. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212641 M2A-T M/H RAD 2HL SHL 41/56MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 141430

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R