BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 1012287 · Received March 14, 2008

    Report

    Report Number
    9613350-2008-00011
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    December 13, 2007
    Report Date
    March 11, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. A CHECK OF THE MANUFACTURING PAPERS OF ALL MENTIONED PARTS DID NOT SHOW ANY DEVIATIONS TO THEIR SPECIFICATIONS. NO OTHER COMPLAINTS HAVE BEEN REC'D FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PHYSICIAN FOLLOWED SURGICAL TECHNIQUE BY REAMING LINE TO LINE. AFTER REAMING THE ACETABULAR TO 56 MM, ASKED FOR A 56 MM CUP. UPON ATTEMPTING TO INSERT THE CUP WOULD NOT PRESS-FIT INTO ACETABULAR. AFTER 45 MINUTES OF TRYING, PHYSICIAN SWITCHED TO A FIBER METAL CUP AND SCREWS. CLAIMED THE DUROM CUP WAS TOO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH NA 2341970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R