BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 9700210 · Received February 12, 2020

    Report

    Report Number
    0001825034-2020-00659
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    October 16, 2018
    Report Date
    April 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677135
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115370, COMPREHENSIVE REVERSE TRAY, LOT # 812250, CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 094640, CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 341040, CATALOG #: EP-115395, E1 44-36 RTNV +3 HMRL BRG, LOT # 961540, CATALOG #: 405800 , COMP. REV SHLDR 9 IN STEINMANN, LOT # 462740, CATALOG#: 180551, COMP LK SCREW, LOT #: 042460, CATALOG#: 180550, COMP LK SCREW, LOT #: 378700, CATALOG#: 115394, COMP RVS CNTRL, LOT #: 933530. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05083, 0001825034-2019-05084, 0001825034-2019-05085, 0001825034-2019-05099, 0001825034-2020-00655, 0001825034-2020-00656, 0001825034-2020-00658, 0001825034-2020-00659, 0001825034-2020-00660. PRODUCT WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION ABOUT 2 MONTHS LATER DUE TO A POST OPERATIVE INFECTION AND A 2 STAGE ANTIBIOTIC SPACER PLACEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166411 COMP LK SCR 3.5HEX 4.75X15 ST FASTENER, FIXATION KWS ZIMMER BIOMET, INC. N/A 699700 00880304677135

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R