BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: CC E CC LIGHT HOODED PE HC FIXED 32 / F

    MDR report key: 10008594 · Received April 29, 2020

    Report

    Report Number
    3005180920-2020-00264
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    April 1, 2020
    Report Date
    May 27, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807602
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISED CERAMIC HIP HEAD IS NOT MARKETED IN THE USA. ANYWAY THE BALL HEAD SUPPLIER REPORTS ABOUT THE BALL HEAD LOT: PROTOCOLS AND CERTIFICATE OF CONFORMANCE WERE REVIEWED. THE QUALITY DOCUMENTS SHOW THAT THE VALUES OBTAINED ON THE BALL HEAD WERE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE COMPONENT PROPERTIES AND THE MICROSTRUCTURE AS OBTAINED FROM THA QUALITY DOCUMENTS FULFIL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MAERIAL DEFECT. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 APRIL 2020: LOT 102330: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2010. EXPIRATION DATE: 2015-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM SINCE 2016. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 9 YEARS AFTER PRIMARY CEMENTLESS THA THE PATIENT SUFFERS A DISLOCATION AND THEREFORE THE CUP IS REPLACED TO A DUAL MOBILITY SYSTEM. A POSSIBLE CAUSE FOR THE EVENT IS INCREASED LUMBAR STIFFNESS, COUPLED WITH A CUP THAT HAD LITTLE ANTEVERSION. NO REASON TO SUSPECT A DEFECTIVE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN COMPLAINING OF INSTABILITY AFTER AN INCIDENT OF BENDING OVER AND LIFTING SOMETHING. THE SURGEON THEN REVISED HEAD AND LINER (8 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY) IN ORDER TO IMPLANT A DUAL MOBILITY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474483 LINER: CC E CC LIGHT HOODED PE HC FIXED 32 / F HIP SHELL LINER LZO MEDACTA INTERNATIONAL SA 01.26.3248HCAT 102330 07630030807602

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention