BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER CUP

    MDR report key: 6330517 · Received February 14, 2017

    Report

    Report Number
    0001822565-2017-00871
    Event Type
    Injury
    Date Received
    February 14, 2017
    Report Date
    February 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. A2 - DATE OF BIRTH/AGE - NI. A3 - GENDER - NI. A4 - WEIGHT - NI. B3 - DATE OF EVENT - NI . D4 - EXPIRATION DATE - NI. D4 - UNIQUE IDENTIFIER (UDI) # - NI. D6 - DATE IMPLANTED - NI. D7 - DATE EXPLANTED - NI. H4 - MANUFACTURE DATE ¿ NI. AMENABAR ET AL. "PROMISING MID-TERM RESULTS WITH A CUP-CAGE CONSTRUCT FOR LARGE ACETABULAR DEFECTS AND PELVIC DISCONTINUITY." CLINICAL ORTHOPAEDICS AND RELATED RESEARCH. 474:408¿414. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001822565-2017-00865/866/872/875 ).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT A PATIENTS HIP ARTHROPLASTY WAS REVISIED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113148 UNKNOWN ZIMMER CUP HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R