BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 L

    MDR report key: 7204883 · Received January 19, 2018

    Report

    Report Number
    3005180920-2017-00849
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 18, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018: LOT 172270: 102 ITEMS MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 73 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 SIMILAR REPORTED EVENT. CERAMIC LINER Ø 36 / E REFERENCE 01.29.413 (NOT MARKETED IN US): LOT 172291: 140 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 62 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED SWELLING AND DISCHARGE FROM HIS HIP OVER A 36 HOUR PERIOD: WASHOUT WITH HEAD AND LINER EXCHANGE 5 DAYS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48303 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 L CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 172270 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention