BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD 50MM HEAD DIAMETER

    MDR report key: 2802029 · Received October 23, 2012

    Report

    Report Number
    0001825034-2012-02123
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    April 30, 2015
    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

    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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY FURTHER PATIENT INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02123 / 02124 & 2014-00712 / 00714).

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2012-02123 / 02124).

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(4) 2009. LEGAL COUNSEL FOR PATIENT REPORTS PATIENT ALLEGATIONS OF PATIENT INJURY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. 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

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY AND ALLEGED SUBSEQUENT PERSONAL INJURY. LEGAL COUNSEL FOR PATIENT FURTHER REPORTED PATIENT ALLEGATIONS OF NEGATIVE EFFECTS TO TISSUE, BONES, MUSCLES AND LIGAMENTS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. A REVIEW OF INVOICE HISTORY CONFIRMED THAT A RESURFACING HIP PROCEDURE WAS PERFORMED ON (B)(6), 2006 AND A TOTAL HIP ARTHROPLASTY PROCEDURE TOOK PLACE ON (B)(6), 2009. ADDITIONAL INFORMATION PROVIDED IN PATIENT MEDICAL RECORDS CONFIRMED THE RESURFACING PROCEDURE THAT OCCURRED ON (B)(6), 2006 WAS FOR THE RIGHT HIP. REVISION OPERATIVE NOTES PROVIDED INDICATE THAT A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 TO REMOVE AND REPLACE THE FEMORAL RESURFACING HEAD DUE TO PSEUDOARTHROSIS AND FATIGUE FRACTURE OF THE FEMORAL NECK. THE TOTAL HIP ARTHROPLASTY THAT WAS PERFORMED ON (B)(6), 2009 WAS FOR THE LEFT HIP. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM MODULAR HEAD 50MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 463600

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R