BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMD

    MDR report key: 8770444 · Received July 9, 2019

    Report

    Report Number
    3005180920-2019-00552
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 10, 2019
    Report Date
    July 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21.06.2019: LOT: 164724: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18.10.2016. EXPIRATION DATE: 02.10.2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 2 YEARS AFTER PRIMARY CEMENTLESS DM THA THE PATIENT REPORTS PAIN AND INSTABILITY. THE INTRAOPERATIVE IMAGE SUPPLIED DOES NOT HELP IN ANY WAY, THE COMPONENTS SEEM TO BE CORRECTLY POSITIONED. THE SURGEON REPLACED THE COMPONENTS WITH IDENTICAL ONES (SAME SIZES) SO WE CANNOT DRAW ANY USEFUL HINT FROM THE REPLACEMENTS CHOSEN. WE ARE UNABLE TO DRAW ANY CONCLUSION. ADDITIONAL IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 21.06.2019: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 167029. LOT 167029: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30.01.2017. EXPIRATION DATE: 18.01.2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. DOCUMENT REVIEW PERFORMED BY CERAMIC HEAD MANUFACTURER (BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 167029): DUE TO LACK OF INFORMATION OF THE LASER ENGRAVING, THE IDENTIFICATION OF THE BALL HEAD IS ONLY POSSIBLE BASED ON THE INFORMATION PROVIDED BY MEDACTA. THE BALL HEAD TO THE SHOP ORDER (B)(4). 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 AT THE MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS FULFILL THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECTS. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CANNOT BE DONE.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 2 YEARS AFTER THE PRIMARY DUE TO PAIN AND INSTABILITY (THE CAUSE IS UNKNOWN). THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REVISED THE VERSAFITCUP DM LINER HC 48/28 WITH VERSAFITCUP DM LINER HC 48/28 AND REVISED THE 28MM BIOLOX DELTA HEAD M WITH A 28MM BIOLOX OPTION HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565236 LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMD DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 164724 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention