BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM

    MDR report key: 7128078 · Received December 19, 2017

    Report

    Report Number
    0001825034-2017-11154
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    September 15, 2014
    Report Date
    February 14, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 11151, 0001825034 - 2017 - 11152, 0001825034 - 2017 - 11153, 0001825034 - 2017 - 11155, 0001825034 - 2017 - 11156. CONCOMITANT: FEMORAL HEAD,UNKNOWN PART/LOT; ACETABULAR LINER, UNKNOWN PART/LOT; ACETABULAR CUP, UNKNOWN PART/LOT; 11-302102 ARCOS TROCH CLAW LOT 085570; 11-302142 ARCOS LATERAL TROCH LOT 398520. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: REGEN/RNGLC+ MULTI 56MM SZ 24 CATALOG#: PT-106056 LOT#: 360640; 32MM MOD HEAD COCR +3MM NECK CATALOG#: 163670 LOT#: 00J3235778; 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; UNKNOWN SCREW CATALOG#: NI LOT#: NI; RINGLOC-X E1 H/W 54/32MM 24 CATALOG#: EP-053254 LOT#: 3276013. 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. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S., HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K090757. THIS EVENT HAS BEEN PREVIOUSLY REPORTED IN 0001825034-2015-01574 WITH NOTIFICATION DATE (B)(6) 2015. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11151; 0001825034-2017-11152; 0001825034-2017-11155; 0001825034-2017-11156; 0001825034-2018-00981; 0001825034-2018-00985; 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
    909735 ARCOS HA MODULAR REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 504230

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R