BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

    MDR report key: 9847173 · Received March 18, 2020

    Report

    Report Number
    3005180920-2020-00167
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 18, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802065
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2020: LOT 182662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-08-20. 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: CUP: VERSAFITCUP CC TRIO 01.26.45.0054 ACETABULAR SHELL CC TRIO 54 (K103352) LOT. 180907 BATCH REVIEW PERFORMED ON 18 MARCH 2020: LOT 180907: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-APR-2018. EXPIRATION DATE: 2023-04-19. 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. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE L + 4 (K112115) LOT. 183363 BATCH REVIEW PERFORMED ON 18 MARCH 2020: LOT 183363: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-SEP-2018. EXPIRATION DATE: 2023-08-30. 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: LINER: CC E CC LIGHT 01.26.3644HCT FLAT PE HC LINER 36 / E (K103352) LOT. 181716. BATCH REVIEW PERFORMED ON 18 MARCH 2020: LOT 181716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2018. EXPIRATION DATE: 2023-05-28. 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

    REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY DUE TO INFECTION. ALL IMPLANTS SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310570 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.025 182662 07630030802065

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention