BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALU FEM HEAD D32/-4/5 42/12-14

    MDR report key: 5655758 · Received May 16, 2016

    Report

    Report Number
    3006946279-2016-00073
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    November 4, 2015
    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. 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 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3006946279-2016-00073 / 00074).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. AN INVESTIGATION OF THE COMPLAINT HAS BEEN PERFORMED CONSISTING OF A DOCUMENTARY REVIEW. THE REVIEW OF MANUFACTURING HISTORY 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. UDI# (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED ON THE LEFT SIDE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO FRACTURE OF THE CERAMIC HEAD. THE CERAMIC HEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311319 ALU FEM HEAD D32/-4/5 42/12-14 PROSTHESIS, HIP LZO BIOMET FRANCE S.A.R.L. N/A 0000241450

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R