BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEMORAL HEAD Ø32/ 0MM T1

    MDR report key: 6374657 · Received March 2, 2017

    Report

    Report Number
    3002806535-2017-00105
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    December 5, 2016
    Report Date
    March 2, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: PN 110003629, LN 3409702, BIOLOX DELTA CER LNR 32MM G. PN 010000666, LN 3789267, G7 PPS LTD ACET SHELL 58G. PN 192112, LN 876340, BI-METRIC ECHO PC LAT 12X140.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT HIP CLOSED REDUCTION PROCEDURE APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154985 DELTA CERAMIC FEMORAL HEAD Ø32/ 0MM T1 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2016031399

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R