BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK

    MDR report key: 8883102 · Received August 12, 2019

    Report

    Report Number
    3005180920-2019-00681
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    June 18, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802607
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JULY 2019: LOT 187005: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2018. EXPIRATION DATE: 2023-11-12. 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 IMPLANTS- BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5, LOT 176812 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAR-2018. EXPIRATION DATE: 2023-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 3 SIMILAR REPORTED EVENT. LINER: MPACT DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF LOT 168641 (K092265): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2019. EXPIRATION DATE: 2022-02-22. 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. CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52, LOT 185435 (K143453): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2018. EXPIRATION DATE: 2023-11-26. 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

    ABOUT 3 MONTHS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679791 STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 187005 07630030802607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention