BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E

    MDR report key: 9255107 · Received October 30, 2019

    Report

    Report Number
    3005180920-2019-00922
    Event Type
    Injury
    Date Received
    October 30, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 30, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807572
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 OCTOBER 2019. LOT 1900236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 2024-03-03. 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. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115) LOT. 189641. BATCH REVIEW PERFORMED ON 14 OCTOBER 2019. LOT 189641: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-FEB-2019. EXPIRATION DATE: 2024-02-07. 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.

    Description of Event or Problem · 1

    DURING A FOLLOW UP, THE SURGEON DISCOVERED THAT THE PATIENT HAD SUBCUTANEOUS STORAGE AREA WITH DEEDING OF THE WOUND ON THE DISTAL PART AND IMBIBITION OF TISSUES AND REDDENING. FEW DAYS LATER THE PATIENT WAS REVISED, LINER AND HEAD WERE REMOVED, PROBABLY DUE TO INFECTION, PATHOGEN IS STAPHYLOCOCCUS AUREUS. THE REVISION HAS BEEN PERFORMED 20 DAYS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052183 LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E ACETABULAR LINER LZO MEDACTA INTERNATIONAL SA 1900236 07630030807572

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention