BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3

    MDR report key: 10257289 · Received July 10, 2020

    Report

    Report Number
    3005180920-2020-00397
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 11, 2020
    Report Date
    July 10, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 170871: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2017. EXPIRATION DATE: 2022-07-19. 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. OTHER DEVICES INVOLVED IN THE EVENT: CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 LOT. 173466 (K103352). BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 173466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2017. EXPIRATION DATE: 2022-09-07. 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. BALL HEADS: COCR 01.25.022 COCR BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 180641 (K072857). A BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 180641: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2018. EXPIRATION DATE: 2023-05-21. 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. LINER: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E LOT. 171719 (K103352). A BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 171719: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2017. EXPIRATION DATE: 2022-07-03. 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.

    Description of Event or Problem · 1

    2ND INFECTION OF THR REQUIRING REVISION SURGERY TO REMOVE ALL IMPLANTS AFTER 2 YEARS AND 5 MONTHS FROM THE PRIMARY SURGERY. THE FIRST INFECTION AND REVISION OF HEAD AND LINER WAS DONE IN (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725473 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.12.023 170871 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention