BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 7605417 · Received June 15, 2018

    Report

    Report Number
    3005180920-2018-00432
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 17, 2018
    Report Date
    January 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVISION PERFORMED ON DEC 5. THE SURGEON CONVERTED THE BIPOLAR HIP TO A TOTAL HIP. THE BIPOLAR HEAD AND COCR HEAD WERE REVISED WITH A COCR HEAD AND A LINER AND CUP WERE IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JUNE 2018. LOT 134769: 60 ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2013, EXPIRATION DATE: 31 OCTOBER 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BALL HEAD: 12/14 Ø 22, SIZE S- 2,5, REFERENCE (B)(4). LOT 134979: 24 ITEMS MANUFACTURED AND RELEASED ON 29 NOVEMBER 2013. EXPIRATION DATE: 31 OCTOBER 2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BIPOLAR HEAD: Ø22X41, REFERENCE (B)(4). LOT 112862: 20 ITEMS MANUFACTURED AND RELEASED ON 19 OCTOBER 2011. EXPIRATION DATE: 30. SEPTEMBER.2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    WE WERE INFORMED ON (B)(6) 2018 THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN IS UNKNOWN AT THIS TIME. THE SURGEON PLANS TO REVISE THE BIPOLAR SYSTEM TO A THA ON (B)(6) 2018. ON (B)(6) 2018 WE WERE INFORMED THAT THE REVISION HAS BEEN CANCELLED. AT THIS TIME THE SURGERY HAS NOT BEEN RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448818 AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 134769 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention