BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 STD, SHORT NECK

    MDR report key: 6356456 · Received February 24, 2017

    Report

    Report Number
    3005180920-2017-00068
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 24, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE THIRD REVISION SURGERY UNDERWENT BY THIS PATIENT. THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2016. HE CAME IN COMPLAINING OF PAIN DUE TO HIP DISLOCATION AND ON (B)(6) 2016. THE SURGEON REVISED THE CUP, HEAD AND LINER (MDR 2016-00722). ON (B)(6) 2017 THE PATIENT HAD A SECOND REVISION (MDR 2017-00034) BECAUSE THE SURGEON DETERMINED THE FEMUR WAS FRACTURED. NO TRAUMA WAS REPORTED. THE SURGEON REVISED THE STEM, HEAD AND LINER. FINALLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. ON 17 FEBRUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: EARLY INFECTION OCCURRED 10 DAYS AFTER RE-REVISION SURGERY. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING THA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICE. BATCH REVIEW PERFORMED ON 23 FEBRUARY 2017. LOT 142580: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 JULY 2014. EXPIRATION DATE: 2019-05-31. 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. MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58, CODE 01.32.158MB, LOT. 162391 (K143453) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-07-05. 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. COCR BALL HEAD 12/14 Ø 28 SIZE L +3.5, CODE 01.25.013, LOT. 160667 (K072857) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MARCH 2016. EXPIRATION DATE: 2021-03-13. 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. DOUBLE MOBILITY HC LINER 28/DM, CODE 01.26.2858MHC, LOT. 160255 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 APRIL 2016. EXPIRATION DATE: 2021-03-31. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED, THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA PRODUCTS AND INPUT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE, EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138484 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 6 STD, SHORT NECK CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 142580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention