BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALU FEM HEAD D32/0/5 42/12-14

    MDR report key: 5655760 · Received May 16, 2016

    Report

    Report Number
    3006946279-2016-00074
    Event Type
    Injury
    Date Received
    May 16, 2016
    Report Date
    April 16, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY WERE NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: INITIAL REPORTER - NAME NI. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051411. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00073 / 00074). PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION OF THE COMPLAINT HAS BEEN PERFORMED CONSISTING OF A DOCUMENTARY REVIEW. THE REVIEW OF MANUFACTURING DHR SHOWS THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. ACCORDING TO THE AVAILABLE DATA AND AS THE PRODUCT HAS NOT BEEN RETURNED FOR INSPECTION, THE EXACT ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THREE MONTHS POST-IMPLANTATION THE PATIENT ALLEGES AUDIBLE NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311233 ALU FEM HEAD D32/0/5 42/12-14 PROSTHESIS, HIP LZO BIOMET FRANCE S.A.R.L. N/A 0000877086

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R