BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER NCB PLATE

    MDR report key: 6651941 · Received June 19, 2017

    Report

    Report Number
    0001822565-2017-04097
    Event Type
    Injury
    Date Received
    June 19, 2017
    Report Date
    June 15, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GHARGOZLOO ET AL. "THE POLYAXIAL LOCKING PLATE OSTEOSYNTHESIS IN PROXIMAL HUMERAL FRACTURES: OUR EXPERIENCE WITH A 4-YEAR FOLLOW-UP" . REFERENCE JOURNAL ARTICLE ATTACHED. J ORTHOPAED TRAUMATOL (2014) 15 (SUPPL 1):S1¿S44 DOI 10.1007/S10195-014-0314-Y. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE ARTICLE WAS WRITTEN BY (EXERTED FROM ORAL PRESENTATIONS AND ORAL COMMUNICATIONS) G. LOGROSCINO, F. DONATI, G. MALERBA1, G. SALONNA, C. ASCANI, C. BERTONE, D. PETRICCIOLI, G.G. CERULLI AT HOSPITALS: ISTITUTO DI CLINICA ORTOPEDICA E TRAUMATOLOGICA, UNIVERSITA` CATTOLICA DEL SACRO CUORE (ROME, IT); U.O.CHIRURGIA DELLA SPALLA E DEL GOMITO OSPEDALE CTO (ROME, IT); ISTITUTO CLINICO CITTA DI BRESCIA-GRUPPO OSPEDALIERO SAN DONATO (BRESCIA, IT), ADDITIONALLY D. GHARGOZLOO, V.F. CARUSO, P. FORTUNA, A. ARANCIO, A. TOMARCHIO, S. AVONDO AT HOSPITALS : CLINICA ORTOPEDICA UNIVERSITARIA, OSPEDALE VITTORIO EMANUELE (CATANIA, IT); UO ORTOPEDIA E TRAUMATOLOGIA, OSPEDALE ¿¿R. GUZZARDI¿¿ VITTORIA (RG), ASP7 RAGUSA (RAGUSA, IT). THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWENTY-ONE (21) PATIENTS HAVE EXPERIENCED JOINT STIFFNESS WITH MODERATE FUNCTIONAL IMPAIRMENT WITHIN FOUR (4) YEARS POST-OPERATIVELY OF A POLYAXIAL LOCKING PLATE OSTEOSYNTHESIS FOR PROXIMAL HUMERAL FRACTURES. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432375 UNKNOWN ZIMMER NCB PLATE HRS ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other