BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM SIZE 6 LAT

    MDR report key: 5087159 · Received September 18, 2015

    Report

    Report Number
    3005180920-2015-00198
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    August 19, 2015
    Report Date
    December 11, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: AMISTEM H 01.18.146 HA COATED LAT STEM #6 LOT. 093026: LOT 093026: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 MARCH 2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. AMISTEM H 01.18.146 HA COATED LAT STEM #6 LOT. 091424 (K093944): LOT 091424: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 AUGUST 2009. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON (B)(4) 2015 THE MEDICAL AFFAIRS STATED THAT WITH THE AVAILABLE INFORMATION, TO DATE NO CLINICAL INVESTIGATION CAN BE PERFORMED. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ON 11 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    WE HAVE BEEN CONTACTED BY A SURGEON, WHO ASKED EXTRA INFORMATION ON THE IMPLANTS. THE ONLY THINGS THAT HE INFORMED US OF WAS THAT A PATIENT MADE A COMPLAINT AGAINST A SURGEON AND THAT HE IS MEDIATING THE CASE. HE INFORMED US ABOUT THE SIZES OF THE IMPLANTS, THAT THE SURGERY TOOK PLACE IN 2010 AND THAT IT WAS A BILATERAL SURGERY. HAVING THIS INFORMATIONS, THE ONLY CASE THAT WE COULD FIND OUT IS A SURGERY ON (B)(6) 2010. WE DON'T KNOW WHAT IS THE REASON FOR THE COMPLAINT. WE ONLY KNOW THAT BOTH HIPS HAVE BEEN REVISIONED AND THE IMPLANTS EXCHANGED. WE DON'T KNOW WHEN, WHERE OR BY WHOM THE REVISION TOOK PLACE. WE WILL NOT BE ABLE TO GET THE IMPLANTS AND WILL PROBABLY NOT KNOW ANYTHING ABOUT THE MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618488 AMISTEM H FEMORAL STEM SIZE 6 LAT CEMENTLESS HA COATED FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 093026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention