BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS TROCH CLAW SMALL 100MM

    MDR report key: 7128703 · Received December 19, 2017

    Report

    Report Number
    0001825034-2017-11291
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    May 15, 2015
    Report Date
    February 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 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; UNKNOWN SCREW, CATALOG#: NI, LOT#: NI; RINGLOC-X E1 H/W 54/32MM 24, CATALOG#: EP-053254, LOT#: 3276013. 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; 0001825034-2017-11292; 0001825034-2018-00731; 0001825034-2018-00732; 0001825034-2018-00733.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HEAD, UNKNOWN LINER, UNKNOWN STEM, . UNKNOWN CUP. THE 11-302142, ARCOS LATERAL TROCH BOLT 42 MM, 398520. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2017-11288, 0001825034-2017-11289, 0001825034-2017-11290, 0001825034-2017-11287, 0001825034-2017-11292.

    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
    910320 ARCOS TROCH CLAW SMALL 100MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 085570

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O