BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSYS FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER SIZE 13 250MM

    MDR report key: 20300079 · Received September 25, 2024

    Report

    Report Number
    0002648920-2024-00298
    Event Type
    Death
    Date Received
    September 25, 2024
    Date of Event
    September 10, 2024
    Report Date
    September 25, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    UDI-DI
    00889024140042
    PMA / PMN Number
    K210842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# UNKNOWN LOT# UNKNOWN DEPUY BONE CEMENT G2: FOREIGN: COUNTRY: JAPAN NO PRODUCT WAS RETURNED FOR EVALUATION. IT WAS REPORTED THAT A COMPETITOR PRODUCT WAS BEING REVISED IN A HIP PROCEDURE. AFTER COMPETITOR CEMENTATION AND STEM INSERTION, THE PATIENT'S CARDIAC CONDITION DETERIORATED LEADING TO CARDIAC ARREST WITHOUT RESUSCITATION. THE PATIENT'S AGE AND COMORBID CONDITIONS REMAIN UNKNOWN. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. SIDE EFFECTS OF THE ADMINISTRATION OF ANESTHESIA ARE A KNOWN CAUSE OF CARDIAC STRESS DURING THE INTRAOPERATIVE AND POSTOPERATIVE RECOVERY. MOST PATIENTS WITH A CARDIAC HISTORY WILL HAVE A CARDIAC WORKUP PRIOR TO CLEAR THEM FOR SURGERY TO DEMONSTRATE THE PATIENT'S CARDIAC STATUS IS FIT TO WITHSTAND THE STRESS OF ANESTHESIA, POSITIONING, AND SURGERY. AS THE REPORTED COMPLAINT INDICATED, A CARDIAC COMPLICATION DEVELOPED INTRAOPERATIVELY, BUT ANY FURTHER INTERVENTION WAS INSUFFICIENT TO PREVENT THE TERMINAL OUTCOME. AS THE REPORTED EVENT WAS UNRELATED TO THE IMPLANTED STEM, A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE USING A COMPETITOR'S IMPLANTS. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR A PERIPROSTHETIC FRACTURE. DURING THE REVISION HEMI ARTHROPLASTY SURGERY, THE PATIENT'S CONDITION DETERIORATED, AND THE PATIENT DIED OF CARDIOPULMONARY ARREST. IT IS NOT KNOWN WHETHER THE PATIENT HAD ANY UNDERLYING MEDICAL CONDITIONS THAT MAY HAVE BEEN RELATED TO THE EVENT. THE PATIENT'S CARDIOPULMONARY ARREST OCCURRED AFTER THE BONE CEMENT AND STEM WERE INSERTED INTO THE PATIENT. THE CEMENT IS A COMPETITOR PRODUCT. THE CAUSE OF THE CARDIOPULMONARY ARREST WAS NOT DETERMINED; HOWEVER, NO CAUSAL RELATIONSHIP BETWEEN THE DEATH AND THE PRODUCT HAS BEEN NOTED. THERE WAS NO PATIENT INFORMATION OR MEDICAL RECORDS AVAILABLE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292487 VERSYS FEMORAL STEM CEMENTED REVISION/CALCAR 12/14 NECK TAPER SIZE 13 250MM PROTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 65550751 00889024140042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death