BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 7245910 · Received February 6, 2018

    Report

    Report Number
    0001825034-2018-00733
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    May 15, 2015
    Report Date
    February 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    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: REF 11-302102 LOT 085570. ARCOS LATERAL TROCH BOLT 42MM: REF 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11287, 0001825034-2017-11288 , 0001825034-2017-11290 , 0001825034-2017-11291, 0001825034-2017-11292, 0001825034-2018-00731, 0001825034-2018-00732.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED REDDENING IN THE UPPER LEG AND AN ALLERGIC SKIN REACTION. THE PATIENT WAS TREATED AT HOME WITH CORTISONE CREAM APPLIED LOCALLY TO THE AFFECTED SITE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87259 UNKNOWN SCREW PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other