BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK

    MDR report key: 8764350 · Received July 5, 2019

    Report

    Report Number
    3005180920-2019-00543
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 6, 2019
    Report Date
    July 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802638
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019 WE RECEIVED THE DEVICE VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: FEMORAL STEM AND ACETABULAR SHELL SHOW RESIDUAL BONE AND SIGNS OF REMOVAL OPERATION. FEMORAL HEAD WITH METAL TRANSFER SCRATCH PROBABLY DUE TO EXTRACTION. IT IS NOT POSSIBLE TO DETERMINE AN IMPLANT'S RELATED FAILURE ROOT CAUSE. ON (B)(6) 2019 WE RECEIVED THE NAME OF THE PATHOGEN: STAPHYLOCOQUE EPIDERMIS

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED, 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO INFECTION. THE PATHOGEN IS STAPHYLOCOQUE EPIDERMIS . IMPLANT WAS REMOVED AND A SPACER WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 JUN 2019: LOT 170195: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2017. EXPIRATION DATE: 13-JUNE-2022. 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 ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 17 JUN 2019: CUP: VERSAFITCUP CC TRIO 01.26.45.1152 ACETABULAR SHELL CC TRIO NO-HOLE Ø 52 (K122911), LOT 171706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2017. EXPIRATION DATE: 28-MAY-2022. 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: CC E CC LIGHT 01.26.3244HCT FLAT PE HC LINER Ø 32 / E (K103352), LOT 173568: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2017. EXPIRATION DATE: 31-AUG-2022. 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. IMPLANTS FROM CERAMTEC 38.49.7175.675.00 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 LOT. 7011138362 (ITEM NOT REGISTERED IN USA).

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO INFECTION. THE PATHOGEN IS UNKNOWN. ALL HARDWARE HAS BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558948 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 170195 07630030802638

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention