BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50

    MDR report key: 8953779 · Received September 2, 2019

    Report

    Report Number
    3005180920-2019-00750
    Event Type
    Injury
    Date Received
    September 2, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    UDI-DI
    07630030843716
    PMA / PMN Number
    K091967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 AUGUST 2019: LOT 1900866: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2019. EXPIRATION DATE: 2024-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 13 AUGUST 2019: BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 1811825. LOT 1811825: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2019. EXPIRATION DATE: 2024-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. STEM: AMISTEM-P COLLARED 01.18.435 AMISTEM-P COLLARED STD STEM SIZE5 (K173794), LOT. 1902249. LOT 1902249: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2019. EXPIRATION DATE: 2024-05-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS AND PUT IN NEW HARDWARE 3 WEEKS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747859 BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50 HIP BIPOLAR HEAD KWY MEDACTA INTERNATIONAL SA 1900866 07630030843716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention