BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM- P SHORT NECK STD STEM SIZE 2

    MDR report key: 14267059 · Received May 3, 2022

    Report

    Report Number
    3005180920-2022-00327
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 2, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971243668
    PMA / PMN Number
    K192126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 APRIL 2022. LOT 2113027: 30 ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2022. EXPIRATION DATE: 2027-FEB-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS SPECIALIST DURING A FOLLOW UP VISIT FEW WEEKS AFTER THA, IT WAS NOTICED THROUGH RADIOGRAPHIC IMAGES THAT THE STEM SINKED AND A FRACTURE IN THE DIAPHYSEAL AREA WAS PRESENT. THE SINKING COULD HAVE BEEN CAUSED BY THE FRACTURE. THE SURGEON SUGGESTED A REVISION BUT SINCE THE PATIENT DID NOT REPORT ANY PAIN SHE REFUSED IT. INTRAOPERATIVE FEMORAL FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS, DESCRIBED AND QUANTIFIED IN LITERATURE. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    AT 1 MONTH AFTER THE PRIMARY SURGERY, DURING A FOLLOW-UP VISIT, STEM SINKING ASSOCIATED WITH PERI-STEM FRACTURES IS OBSERVED. HOWEVER, THERE WERE NO COMPLAINTS FROM THE PATIENT SUCH AS PAIN, AND SHE WAS ABLE TO WALK WITHOUT PROBLEMS. THE PATIENT REJECT THE REVISION SURGERY, BUT THE SURGEON WILL CONTINUE TO RECOMMEND REVISION SURGERY. FRACTURE LINES MAY BE SEEN ON X-RAYS POST-PRIMARY. IT IS UNCLEAR WHETHER THE OPERATION OF THE RASPS DURING THE SURGERY WAS BAD, BUT IT MAY BE DUE TO THE FACT THAT THE RASPS WERE TAKEN IN AND OUT MANY TIMES DURING THE SURGERY DUE TO UNFAMILIAR SURGERY. BONE QUALITY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184672 STEM: AMISTEM P AMISTEM- P SHORT NECK STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.462 2113027 07630971243668

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other