BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN M2A-38 HIP

    MDR report key: 4251094 · Received November 14, 2014

    Report

    Report Number
    0001825034-2014-08541
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    January 15, 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
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT THE COMPLAINT ASSOCIATED WITH PATIENT (B)(4) IS A DUPLICATE OF THE COMPLAINT ASSOCIATED WITH PATIENT (B)(4). (B)(4) AND ASSOCIATED MEDWATCH WILL BE CLOSED AS A DUPLICATE AND ANY ADDITIONAL INFORMATION WILL BE ASSESSED ON (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. 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. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. CATALOG NUMBER, LOT NUMBER, EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. DATE EXPLANTED - UNKNOWN. PMA/510(K) NUMBER - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. 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

    SURGEON'S LEGAL COUNSEL REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. LEGAL COUNSEL FURTHER REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE DUE TO INFILTRATION LINFOPLASMACELLARE CAUSED BY THIRD BODY OR REACTION TO THE METAL. THIS REPORT IS BASED ON ALLEGATIONS CONTAINED IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738602 UNKNOWN M2A-38 HIP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R