BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA MODULAR CERAMIC HEAD 36MM

    MDR report key: 6216037 · Received December 30, 2016

    Report

    Report Number
    3002806535-2016-00924
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    November 19, 2016
    Report Date
    December 28, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK042091
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). CONCOMITANT MEDICAL PRODUCTS - MEDICAL PRODUCT - PN: 650-0795, LN: 1203448 BIOLOX DELTA XLW-18 INS 36/44G. PN: 124454HA, LN: 12134373 EXCEED ABT STD SHELL HA/PC 54 MM. PN: 21-123206, LN: 1208994 TAPERLOC LAT. HA/PC 12.5 MM T1.

    Description of Event or Problem · 1

    PATIENT REPORTED AN OCCASIONAL GRINDING NOISE WITH NO OTHER COMPLICATIONS. IT IS UNKNOWN IF THE GRINDING NOISE IS EMANATING FROM THE PATIENT'S RIGHT HIP IMPLANT OR ANATOMIC RIGHT KNEE. THERE IS NO INTERVENTION CURRENTLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865026 BIOLOX DELTA MODULAR CERAMIC HEAD 36MM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 1222843

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR