BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 48ODX42ID

    MDR report key: 2782081 · Received October 11, 2012

    Report

    Report Number
    0001825034-2012-01865
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    February 9, 2010
    Report Date
    November 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. 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. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR INDICATING THE REASON FOR THE REVISION WAS ALLEGEDLY ACETABULAR CUP LOOSENING.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT M2A HIP ARTHOPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO PATIENT ALLEGED PERSONAL INJURIES. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FOURTH IN PLANTIFF'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 M2A HIP ARTHROPLASTY ON (B)(60 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PATIENT ALLEGED PERSONAL INJURIES. ADDITIONAL INFORMATION RECEIVED INDICATES THE REVISION PROCEDURE WAS PERFORMED ALLEGEDLY DUE TO ACETABULAR CUP LOOSENING. ADDITIONAL INFORMATION RECEIVED BY PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGES NEGATIVE AND DETRIMENTAL EFFECTS TO THE TISSUES, BONES, MUSCLES AND LIGAMENTS. 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 M2A HIP ARTHOPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PATIENT ALLEGED PERSONAL INJURIES. ADDITIONAL INFORMATION RECEIVED INDICATES THE REVISION PROCEDURE WAS PERFORMED ALLEGEDLY DUE TO ACETABULAR CUP LOOSENING. ADDITIONAL INFORMATION RECEIVED BY PATIENT'S LEGAL COUNSEL REPORTS PATIENT ALLEGES NEGATIVE AND DETRIMENTAL EFFECTS TO THE TISSUES, BONES, MUSCLES AND LIGAMENTS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS REVEALED THE (B)(6) 2010 REVISION WAS DUE TO PAIN AND POSSIBLE COMPONENT MALPOSITION. THE PATIENT'S OPERATIVE REPORT NOTED FAILURE OF OSTEOINTEGRATION OF THE ACETABULAR COMPONENT.

    Description of Event or Problem · 1

    MEDICAL RECORDS PROVIDED INDICATE REVISION WAS ALLEGEDLY DUE TO ACETABULAR LOOSENING. THE CUP, HEAD AND LINER WERE REMOVED AND REPLACED. 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 M2A HIP ARTHROPLASTY ON (B)(6) 2009. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2010 DUE TO PATIENT ALLEGED PERSONAL INJURIES. ADDITIONAL INFORMATION RECEIVED INDICATES THE REVISION PROCEDURE WAS PERFORMED ALLEGEDLY DUE TO ACETABULAR CUP LOOSENING. THIS REPORT IS BASED ON ALLEGATIONS SET FOURTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 555040

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R