BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION CERAMIC HEADS

    MDR report key: 6533964 · Received May 1, 2017

    Report

    Report Number
    0001825034-2017-02386
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    January 26, 2017
    Report Date
    November 26, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034-2017-02387, 0001825034-2017-02388, 0001825034-2017-02389).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND UPDATED INFORMATION. CONCOMITANT MEDICAL PRODUCTS: CER OPTION TYPE 1 TPR SLEVE +3 P/N 650-1067 L/N 603970. M2A-MAGNUM PF CUP 56ODX50ID P/N US157856 L/N 990940. ACT ARTIC E1 HIP BRG 28 X 50 MM P/N EP-200156 L/ N 093280. TAPERLOC POR FMRL 17.5X155 P/N 103209 L/N 565620. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316217 BIOLOX DELTA OPTION CERAMIC HEADS PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 263690

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R