BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT 01.26.3644HCT FLAT PE HC LINER 36 / E

    MDR report key: 12267570 · Received August 3, 2021

    Report

    Report Number
    3005180920-2021-00644
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 13, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807671
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION: EARLY INFECTION IN CEMENTLESS THAN 4 WEEKS AFTER PRIMARY OPERATION. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JULY 2021. LOT 2013088: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2021. EXPIRATION DATE: 2026-01-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 15 JULY 2021. BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115) LOT. 2011675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MARCH-2021. EXPIRATION DATE: 2026-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A WOUND THAT PURGED. 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON RINSED THE WOUND AND REVISED HEAD AND LINER. SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162565 LINER: CC E CC LIGHT 01.26.3644HCT FLAT PE HC LINER 36 / E HIP LINER FLAT LZO MEDACTA INTERNATIONAL SA 01.26.3644HCT 2013088 07630030807671

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention