BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 54MM

    MDR report key: 3840649 · Received May 30, 2014

    Report

    Report Number
    0001825034-2014-05060
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    October 21, 2013
    Report Date
    April 16, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "MATERIAL SENSITIVITY REACTIONS.¿ AND "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." AND "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 4 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-03049/-03050/-05058/-05060).

    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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED RIGHT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER ALLEGES A RIGHT HIP REVISION TOOK PLACE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, ALTERED GAIT, AND LOSS OF RANGE OF MOTION. NO REVISION HAS BEEN REPORTED ON THE LEFT HIP. ADDITIONAL INFORMATION RECEIVED IN AN OPERATIVE REPORT NOTED PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2013 DUE TO ADVERSE TISSUE EFFECTS. OPERATIVE REPORT FURTHER NOTED FEMORAL HEAD INSTABILITY AND A PSEUDOCAPSULE AND THICKENED SCAR TISSUE THAT APPEARED INFLAMED. THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED AND A LINER WAS IMPLANTED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGATIONS OF PAIN. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2013. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. THERE HAS BEEN NO REPORTED RIGHT HIP REVISION PROCEDURE TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT¿S LEGAL COUNSEL REPORTS PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007 AND A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. LEGAL COUNSEL FURTHER ALLEGES A RIGHT HIP REVISION TOOK PLACE ON (B)(6) 2013 DUE TO PATIENT ALLEGATIONS OF PAIN, SWELLING, INFLAMMATION, DAMAGE TO SURROUNDING BONE AND TISSUE, LACK OF MOBILITY, ALTERED GAIT, AND LOSS OF RANGE OF MOTION. NO REVISION HAS BEEN REPORTED ON THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318935 M2A-38 CUP NON FLARED SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 399050

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R