BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 3181677 · Received June 21, 2013

    Report

    Report Number
    0001825034-2013-02117
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    November 15, 2012
    Report Date
    September 20, 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
    CA, 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. 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 WITH METAL-ON-METAL ARTICULATING SURFACES." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-02114 / 02117).

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND THAT A REVISION PROCEDURE WAS PERFORMED A FEW DAYS AFTER THE INITIAL PROCEDURE ALLEGEDLY DUE TO A MISMATCH BETWEEN THE HEAD AND CUP. THE HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WITH HIP, AND METAL DEBRIS. A REVIEW OF INVOICE HISTORY CONFIRMED THE PRIMARY SURGERY DATE AND THAT THE MODULAR HEAD, ACETABULAR CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED DURING THE REVISION PROCEDURE ON (B)(6) 2012. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN THE REVISION OPERATIVE NOTES FOR THE REVISION PROCEDURE PERFORMED ON (B)(6) 2012 INDICATES THAT IT WAS DUE TO PSEUDOCAPSULE, FLUID COLLECTION, LOOSE ACETABULAR CUP, FIBROUS AND GRANULATION TISSUE WHICH WAS STAINED WITH METAL AND OSTEOLYTIC CYSTS. ALL COMPONENTS WERE REMOVED AND REPLACED. OPERATIVE NOTES ALSO CONFIRMED THAT THE REVISION PROCEDURE IN 2010 WAS PERFORMED TO CORRECT A MISMATCH BETWEEN THE ACETABULAR CUP AND HEAD.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, LEGAL COUNSEL FOR PATIENT REPORTS PATIENT WAS REVISED ON AN UNKNOWN DATE A FEW DAYS AFTER THE INITIAL PROCEDURE ALLEGEDLY DUE TO A MISMATCH BETWEEN THE HEAD AND CUP. THE HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. FURTHER REVISION OCCURRED ON (B)(6) 2012, DUE TO PATIENT ALLEGATIONS OF PAIN, DIFFICULTY WITH HIP, AND METAL DEBRIS. THE HEAD, CUP AND TAPER ADAPTER WERE REMOVED AND REPLACED WITH BIOMET HEAD AND COMPETITOR CUP. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. 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
    282100 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 585470

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R