BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM COLLARED HA COATED STD STEM SIZE 00

    MDR report key: 7845329 · Received September 5, 2018

    Report

    Report Number
    3005180920-2018-00655
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 6, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804540
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 SEPTEMBER 2018 LOT 152554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHERS DEVICES INVOLVED: MECTACER REFERENCE 01.29.203 (K112115) BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 LOT 151722: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP DM 01.26.2850MHC (K092265) DOUBLE MOBILITY HC LINER Ø 50/28 LOT 154206: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2015. EXPIRATION DATE: 2020-10-07 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP GENERIC PAIN. THE REASON OF PAIN IN UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685839 STEM COLLARED HA COATED STD STEM SIZE 00 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 152554 07630030804540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention