BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14

    MDR report key: 12370326 · Received August 26, 2021

    Report

    Report Number
    0009613350-2021-00435
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 22, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430280
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED INFORMATION, THE ISSUE OCCURRED WHEN THE LINER DISLOCATED FROM THE SHELL, BOTH OF WHICH ARE PRODUCTS COVERED IN THE SPLIT CASE ZIMMER INC., WARSAW (B)(4), MFR 0001825034-2021-02412 AND 0001825034-2021-02413). THE BLOOD LOSS AND DELAY OF SURGERY WERE THEN DUE TO THE DISLOCATION. THERE DOES NOT SEEM TO BE ANY ISSUE WITH THE BIOLOX HEAD. THIS CASE WILL BE INVALIDATED. PLEASE DELETE THIS CASE FROM YOUR RECORDS. THE EVENT WILL BE FURTHER REPORTED UNDER (B)(4). ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    BASED ON THE PROVIDED INFORMATION, THE ISSUE OCCURRED WHEN THE LINER DISLOCATED FROM THE SHELL, BOTH OF WHICH ARE PRODUCTS COVERED IN THE SPLIT CASE ZIMMER INC., WARSAW (B)(4), MFR 0001825034-2021-02412 AND 0001825034-2021-02413). THE BLOOD LOSS AND DELAY OF SURGERY WERE THEN DUE TO THE DISLOCATION. THERE DOES NOT SEEM TO BE ANY ISSUE WITH THE BIOLOX HEAD. THIS CASE WILL BE INVALIDATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: M2A-MAGNUM PF CUP 46ODX40ID; CATALOG#: US157846; LOT#: 702570. ACT ARTIC E1 HIP BRG 28X40MM S46 DIA28; CATALOG#: EP-200146; LOT#: 019650. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    DURING A SURGERY, THE SURGEON FOUND THAT THE IMPLANTED PRODUCTS HAVE DISLOCATED. THE ISSUE WAS NOT SOLVED DESPITE OF REPEATED TESTS. THE PATIENT'S BLOOD LOSS INCREASED AND THERE WAS A SURGICAL DELAY OF 90 MINUTES. HENCE, THE SURGERY WAS COMPLETED WITH CONTINUUM PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267988 BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN 00889024430280

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization SEE H10 NARRATIVE