BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISODUR PROSTHESIS HEAD 12/14 28MM M

    MDR report key: 4437531 · Received January 16, 2015

    Report

    Report Number
    3005673311-2015-00010
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Report Date
    January 16, 2015
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    LPH
    PMA / PMN Number
    K040191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) #: K040191/K081973. US REPORTING AGENT NOTIFIED ON (B)(4) 2015. MFG SITE EVAL: COMPONENT IN USE WITH REPORTED DEVICE ARE: HIP PROSTHESIS: THIRD PARTY. ACETABULUM CUP: THIRD PARTY. POLYETHYLENE INSERT: THIRD PARTY. MFG RECORDS REVIEWED AND NO DEVIATIONS REGARDING MATERIAL OR PRODUCT WERE FOUND. METAL HEAD SHOWS INDICATIONS OF WEAR. ALSO, CERAMIC RESIDUES WERE NOTED, WHICH WERE PRESSED INTO THE ARTICULATION SURFACE OF THE POLYETHYLENE INSERT AND THE METAL HEAD. THE WEAR DEBRIS OF METAL HEAD IS TRACED BACK TO IMPRESSED CERAMIC FRAGMENTS IN THE CUP. WEAR DEBRIS OF THE METAL HEAD IS THE RESULT OF THIRD-BODY WEAR BETWEEN THE POLYETHYLENE CUP, REMAINING CERAMIC FRAGMENTS (FROM REVISION SURGERY IN 2010) AND THE METAL HEAD. THE ROOT CAUSE OF METALLOSIS CAN BE TRACED BACK TO THE REMAINING CERAMIC FRAGMENTS OF THE FIRST REVISION SURGERY.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). ON 2010, REVISION SURGERY DUE TO BROKEN CERAMIC HEAD. THE PT ORIGINALLY HAD A J AND J HIP PACKET: DURALOC WITH PET INSERT, A CERAMIC HEAD AND A CORAIL STEM. REVISION SURGERY CHANGED TO AESCULAP PRODUCTS: METAL HEAD ISODUR M DIAM 28. ON 2014, PT CAME TO EMERGENCY ROOM EXPERIENCING SEVERE CHRONIC COBALT INTOXICATION MANIFESTED AS RENAL FAILURE, CARDIOMYOPATHY, HEADACHES ETC. PT IGNORED ALL REGULAR EXAMS FROM TIME OF REVISION (2010) TO THE TIME OF ARRIVAL AT E.R. (2014). ALL IMPLANTS WAS EXPLANTED DUE TO ENORMOUS LOCAL BODY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40908 ISODUR PROSTHESIS HEAD 12/14 28MM M HIP ENDOPROSTHESIS LPH AESCULAP AG AND CO. KG NK430K 51341089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other