BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4

    MDR report key: 8780215 · Received July 11, 2019

    Report

    Report Number
    3005180920-2019-00562
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ABOUT 8 YEARS AFTER PRIMARY REVISION SURGERY FOR STEM ASEPTIC LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JULY 2019: LOT 110577: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-"MAG"-2011. EXPIRATION DATE: 2016-03-31. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY EVENT REPORTED. OTHER DEVICES WERE INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 09 JULY 2019: CUP: VERSAFITCUP CC TRIO 01.26.45.0056 ACETABULAR SHELL CC TRIO Ø 56 LOT. 104042 (K103352): (B)(4)ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2011. EXPIRATION DATE: 2016-01-31. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY EVENT REPORTED. LINER: CC E CC LIGHT 01.26.3648HCT FLAT PE HC LINER Ø 36 / F LOT.110577 (K103352): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2010. EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY EVENT REPORTED. BALL HEADS: MECTACER 38.49.7179.285.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 LOT. 666512 (ITEM NOT REGISTERED IN USA).

    Description of Event or Problem · 1

    ABOUT 8 YEARS AFTER PRIMARY THE SURGEON PLANS TO REVISE THE PATIENT HIP. THE REASON OF REVISION IS UNKNOWN FOR THE MOMENT. THE SURGEON PLANS TO REVISE THE LINER, BALL HEAD AND THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574569 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 110577 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention