BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CEMENT SPACER MOLD

    MDR report key: 6914228 · Received October 4, 2017

    Report

    Report Number
    0001825034-2017-07630
    Event Type
    Injury
    Date Received
    October 4, 2017
    Date of Event
    July 19, 2009
    Report Date
    September 29, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWL
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN. THE EVENT OCCURRED IN (B)(6). REPORT SOURCE: LITERATURE: KENT, MATTHEW, ET AL. ¿A TECHNIQUE FOR THE FABRICATION OF A REINFORCED MOULDED ARTICULATING CEMENT SPACER IN TWO-STAGE REVISION TOTAL HIP ARTHROPLASTY.¿ INTERNATIONAL ORTHOPAEDICS, VOL. 34, NO. 7, 2009, PP. 949¿953., DOI:10.1007/S00264-009-0847-5. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 IN A JOURNAL ARTICLE THAT ONE PATIENT EXPERIENCED PERI-SPACER FRACTURE DUE TO MINIMAL TRAUMA. THE FRACTURE OCCURRED IN A REGION OF SEVERE OSTEOLYSIS. NO INTERVENTION WAS NECESSARY AS THE SPACER WAS REPLACED AT THE SECOND STAGE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693830 UNK CEMENT SPACER MOLD INSTRUMENT, HIP KWL ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PALOCOS CEMENT, PART/LOT UNKNOWN