BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 7275088 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-00985
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    September 15, 2014
    Report Date
    February 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ON INITIAL INFORMATION AND INVESTIGATION RESULTS. CONCOMITANT MEDICAL PRODUCTS: REGEN/RNGLC+ MULTI 56MM SZ 24 CATALOG#: PT-106056 LOT#: 360640, 32MM MOD HEAD COCR +3MM NECK CATALOG#: 163670 LOT#: 00J3235778, ARCOS 17X190MM SPL TPR DIST HA CATALOG#: 22-300917 LOT#: 504230, ARCOS TROCH CLAW SMALL 100MM: CATALOG#: 11-302102 LOT#: 085570, ARCOS LATERAL TROCH BOLT 42MM: CATALOG#: 11-302142 LOT#: 398520, ARCOS CON SZ A STD 70MM HA CATALOG#: 22-301321 LOT#: 013730, UNKNOWN SCREW CATALOG#: NI LOT#: NI, RINGLOC-X E1 H/W 54/32MM 24 CATALOG#: EP-053254 LOT#: 3276013. FOREIGN: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. THIS EVENT HAS BEEN PREVIOUSLY REPORTED IN 0001825034-2015-01574 WITH NOTIFICATION DATE MAR 23, 2015. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11151, 0001825034-2017-11152, 0001825034-2017-11154, 0001825034-2017-11155, 0001825034-2017-11156, 0001825034-2018-00981, 0001825034-2018-00988.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR 11 DAYS TO ADDRESS WOUND DRAINAGE POST-PRIMARY HIP REPLACEMENT. THE OUTCOME WAS CONSIDERED RESOLVED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118782 UNKNOWN SCREW PROSTHESIS, HIP HWC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R