BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS STEM #5 STD

    MDR report key: 4861501 · Received June 19, 2015

    Report

    Report Number
    3005180920-2015-00128
    Event Type
    Injury
    Date Received
    June 19, 2015
    Product Code
    MEH
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 2, IT WAS COMMUNICATED THAT THE X-RAY WERE REQUESTED BUT NOT YET RECEIVED. ON JULY 22, WE RECEIVED THE X-RAY. ON JULY 27, THEY HAVE BEEN CHECKED BY THE MEDICAL AFFAIRS DIRECTOR WITH THE FOLLOWING COMMENTS: THE ORIGINAL AMISTEM LOOKS IMPLANTED PERFECTLY IN A DORR-TYPE A FEMUR. SIGNS OF DIFFUSED PROXIMAL RADIOLUCENCY ARE VISIBLE AT THE CONTROL XRAY. NO INFORMATION IS AVAILABLE AS TO THE CLINICAL STATUS OF THE PATIENT. HOWEVER, THE XRAYS REPRESENT A CASE THAT IS COMPATIBLE WITH CONDITIONS OF IDIOPATIC ASEPTIC LOOSENING. THE CEMENTED FEMORAL SHOULD BE THE IDEAL SOLUTION FOR THIS TYPE OF PROBLEM. THE UNPROMISING RADIOGRAPHICAL EVALUATION WAS DETECTED EARLY AND THEREFORE AN EASY REVISION COULD BE PERFORMED. THE ROOT CAUSE FOR PRIMARY UNFAVOURABLE OUTCOME COULD NOT BE DETERMINED. ON 27 JULY, 2005, IT WAS PREPARED A FINAL REPORT WITH THE INFO COLLECTED DURING THE INVESTIGATION, ALREADY REPORTED IN THE INITIAL REPORT AND HERE ABOVE. ON THE SAME DAY, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 111227 - (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06/06/2011. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED ISSUE. ON 06/19/2015, THE R&D PROJECT MANAGER INSPECTED THE RETRIEVED STEM WITH THE FOLLOWING ANALYSIS: OBSERVING THE EXPLANTED FEMORAL STEM, PRESENCE OF HA COATING CAN BE NOTICED IN THE PROXIMAL PART OF THE PROSTHESIS; A SMALL AMOUNT OF BONE CAN BE SEEN ATTACHED TO THE COATING. ALSO, NEAR THE TIP OF THE STEM PRESENCE OF HA COATING CAN BE NOTICED; A SMALL AMOUNT OF BONE CAN BE SEEN ATTACHED TO THE COATING. WHILE, THE HA COATING IS NOT PRESENT IN THE CENTRAL PART OF THE STEM. NO CONCLUSION CAN BE DETERMINED BY THE VISUAL INSPECTION. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. X-RAYS HAVE NOT BEEN RECEIVED YET: WE ASKED FOR THEM AGAIN ON (B)(4) 2015 (PREVIOUS REQUESTS ON (B)(4) 2015).

    Description of Event or Problem · 1

    IMP #: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398948 AMISTEM H CEMENTLESS STEM #5 STD CEMENTLESS FEMORAL STEM, MEH, LZO MEH

    Patients

    Seq Age Sex Outcome Treatment
    1