BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9932414 · Received April 7, 2020

    Report

    Report Number
    3005180920-2020-00235
    Event Type
    Injury
    Date Received
    April 7, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 7, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802737
    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 (B)(6) 2020: LOT 182709: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2018. EXPIRATION DATE: 2023-07-23. 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. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON (B)(6) 2020: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 (K112115), LOT 1900798: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAY-2019. EXPIRATION DATE: 2024-04-15. 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 HAD A PRIMARY SURGERY AND WAS IMPLANTED WITH COMPETITOR COMPONENTS. ON (B)(6) 2020, THE PATIENT CAME IN REPORTING PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR HEAD AND STEM WITH A MEDACTA HEAD AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2020, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THE PATIENT HAD SUPERFICIAL WOUND DRAINAGE. THE SURGEON PERFORMED A WASHOUT AND OBSERVED THAT THE PATIENT'S STEM WAS LOOSE AND THAT NOTHING COULD BE REVISED ANTERIORLY. THE PATIENT WAS CLOSED AND THE SURGEON REVISED THE PATIENT AGAIN ON (B)(6) 2020 USING THE POSTERIOR APPROACH. THE SURGEON REMOVED THE MEDACTA STEM AND HEAD, AND THE COMPETITOR CUP AND LINER, AND REVISED THEM WITH OTHER COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY, 3 WEEKS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395833 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK HIP UNCEMENTED STEM JDI MEDACTA INTERNATIONAL SA 01.12.33SN 182709 07630030802737

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention