BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINN SECTOR W/GRIPTION 56MM

    MDR report key: 2029487 · Received March 24, 2011

    Report

    Report Number
    1818910-2011-03010
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K093646
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS A CUP WHICH WAS TOO VERTICAL, CAUSING DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN SECTOR W/GRIPTION 56MM 87LPH; 87KWA; 87JDI; 87LZO LPH DEPUY ORTHOPAEDICS, INC. NA E27D41000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention