BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9393532 · Received December 2, 2019

    Report

    Report Number
    3005180920-2019-01028
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 2, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    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 20 NOVEMBER 2019: LOT 1900006: 100 ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2019. EXPIRATION DATE: 2024-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 80 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 Ø 36 / E (K103352) LOT. 1900240. BATCH REVIEW PERFORMED ON 19 NOVEMBER 2019: LOT 1900240: 193 ITEMS MANUFACTURED AND RELEASED ON 16-APR-2019. EXPIRATION DATE: 2024-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 174 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50 (K103352) LOT. 1811151. BATCH REVIEW PERFORMED ON 19 NOVEMBER 2019: LOT 1811151: 220 ITEMS MANUFACTURED AND RELEASED ON 10-APR-2019. EXPIRATION DATE: 2024-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 183 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.030 COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5 (K080885) LOT. 130917A. BATCH REVIEW PERFORMED ON 19 NOVEMBER 2019: LOT 130917A: 5 ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2019. EXPIRATION DATE: 2023-12-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 4 MONTHS AFTER PRIMARY REVISION SURGERY FOR INFECTION. ALL HARDWARE REVISED AND A SPACER IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187539 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 1900006 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention