BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SZ 46MM

    MDR report key: 3140736 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01743
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    June 19, 2012
    Report Date
    October 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE AND PATIENT BLOOD TEST RESULTS, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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.

    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 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 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED." NUMBER 4 STATES, ¿LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR.¿ THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01743 AND 1825034-2013-05435).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT LEFT M2A HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A LEFT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO PAIN, ELEVATED ION LEVELS, AND PSEUDOCYST. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO ACETABULAR CUP LOOSENING. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED. PRESENCE OF A PSEUDOCYST WAS NOT CONFIRMED. 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 THE PATIENT REPORTED THAT THE PATIENT UNDERWENT LEFT M2A HIP ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, A REVISION WAS PERFORMED ALLEGEDLY DUE TO PAIN, ELEVATED ION LEVELS, AND PSEUDOCYST. 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
    241602 M2A-MAGNUM MODULAR HEAD SZ 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 474070

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R