BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A CUP

    MDR report key: 2833183 · Received November 15, 2012

    Report

    Report Number
    0001825034-2012-02424
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 23, 2006
    Report Date
    April 13, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01866-1 / 02424).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE ORIGINAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION MAY LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS," AND "PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID." NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, OR EXCESSIVE ACTIVITY." NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-01866-2 & 02424-1).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE INITIAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2006 DUE TO CUP MALPOSITIONING. A FURTHER REVISION WAS PERFORMED ON (B)(6) 2011 DUE TO CUP MALPOSITIONING. 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE INITIAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2006 ALLEGEDLY DUE TO CUP MALPOSITIONING. A FURTHER REVISION WAS PERFORMED ON (B)(6) 2011 DUE TO AN UNKNOWN REASON. 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND REPORTS PATIENT ALLEGATIONS OF PERSONAL INJURY. ADDITIONAL INFORMATION PROVIDED IN OPERATIVE NOTES AND A REVIEW OF INVOICE HISTORY CONFIRMS THE INITIAL HIP ARTHROPLASTY PROCEDURE OCCURRED ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2006 DUE TO CUP MALPOSITIONING. A FURTHER REVISION WAS PERFORMED ON (B)(6) 2011 DUE TO CUP MALPOSITIONING. 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 OPERATIVE REPORTS NOTES A REVISION OCCURRED ON (B)(6) 2006 DUE TO MALPOSITIONING OF ACETABULAR CUP. OPERATIVE REPORT FURTHER NOTED BROWNISH MATERIAL CONSISTENT WITH LOOSENING, WEAR OF THE CUP AND LINER SECONDARY TO SUBLUXATION DURING THE PROCEDURE. THE ACETABULAR CUP AND MODULAR HEAD WERE REPLACED. OPERATIVE REPORTS NOTED PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2011 DUE TO A LOOSE ACETABULAR CUP. OPERATIVE REPORT NOTED HIP CENTER MIGRATION, PERICAPSULAR ADHESIONS AND SCARRING AND WEAR AND MALPOSITIONING OF ACETABULAR CUP. THE MODULAR HEAD AND ACETABULAR CUP WERE REPLACED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN M2A CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R