BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX54MM

    MDR report key: 3973849 · Received August 1, 2014

    Report

    Report Number
    0001825034-2014-06702
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION.¿ NUMBER 6 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 14 STATES, ¿INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿ THIS REPORT IS NUMBER 3 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE (REFERENCE 1825034-2014-04210 & -06701 / -06703).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO BONE/TISSUE AND LACK OF MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT¿S MEDICAL RECORDS INDICATES PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2005 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. IN ADDITION, PATIENT OPERATIVE (OP) NOTES REPORTS PATIENT UNDERWENT A REVISION PROCEDURE ON THE RIGHT HIP ON (B)(6) 2010 DUE TO INFECTION. REVISION OP REPORT NOTES PURULENCE WAS OBSERVED. ALL RIGHT HIP IMPLANTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACERS. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450357 M2A 1 PC SHELL 38MMX54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 351710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization