BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10612477 · Received October 1, 2020

    Report

    Report Number
    3005180920-2020-00660
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    December 19, 2019
    Report Date
    October 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030802157
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 11 SEPTEMBER 2020: LOT 176720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 8-FEB-2018. EXPIRATION DATE: 2023-01-30. 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 DUE TO IMPLANT MOBILIZATION. WITH 2 SIMILAR REPORTED EVENTS DUE TO INFECTION. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 11 SEPTEMBER 2020: CUP: MPACT 01.32.158DH ACETABULAR SHELL Ø58 TWO-HOLES (K132879) LOT. 168448 LOT 168448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2017. EXPIRATION DATE: 2022-02-23. 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: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K1037219) LOT. 168473. LOT 168473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2017. EXPIRATION DATE: 2022-02-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 SIMILAR REPORTED EVENTS. BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 178804. LOT 178804: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2018. EXPIRATION DATE: 2023-04-13. 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 AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY SURGERY DUE TO FEMORAL STEM LOOSENING AND INFECTION. ALL IMPLANTS HAVE BEEN REMOVED. IT IS UNKNOWN IF THE INFECTION CAUSED A MOBILIZATION OR ARE SEPARATE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079169 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.12.033 176720 07630030802157

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention