BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PLATE

    MDR report key: 20294543 · Received September 24, 2024

    Report

    Report Number
    0009613350-2024-00467
    Event Type
    Death
    Date Received
    September 24, 2024
    Date of Event
    January 14, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): B3: THE EVENT HAPPENED ABOUT 4 DAYS AFTER REVISION SURGERY. D10: UNKNOWN ITEM #, UNKNOWN SCREW, UNKNOWN LOT #. G2: REPORT SOURCE UNITED KINGDOM. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. ASPIRATION IS A WELL-KNOWN POSTOPERATIVE COMPLICATION THAT TYPICALLY REQUIRES MEDICAL INTERVENTION AND POSSIBLY EVEN HOSPITALIZATION FOR MORE AGGRESSIVE MEDICAL MANAGEMENT. WITHIN A TWO-HOUR POSTOPERATIVE WINDOW, THE PROTECTIVE REFLEXES OF THE OROPHARYNGEAL PASSAGES ARE DEPRESSED, AND THE PATIENT CAN ASPIRATE. PATIENTS THAT HAVE KNOWN HISTORY OF RESPIRATORY OR LUNG DISEASES SUCH AS COPD, ASTHMA, OR ARE IMMUNE SUPPRESSED ARE AT INCREASED RISK FOR DEVELOPING THIS COMPLICATION. ASPIRATION IS A PROCEDURAL RELATED COMPLICATION RESULTING FROM INTUBATION DURING THE PROCEDURE AND IS CONSIDERED A HOSPITAL-ACQUIRED CONDITION. AS THE COMPLAINT INDICATES, A POSTOPERATIVE COMPLICATION OF ASPIRATION OCCURRED RESULTING IN EXPIRATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1, A2, A3, B3, B4, B5, G3, G6, H2, H6, H10, H11. 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 WAS REVISED DUE TO FATIGUE FAILURE OF DISTAL NCB PLATE. APPROXIMATELY 4 DAYS AFTER THE REVISION SURGERY, THE PATIENT'S CONDITION DETERIORATED AND THEY DIED. A DEFINITIVE CAUSE OF DEATH IS UNKNOWN, ASPIRATION IS SUSPECTED. DUE DILIGENCE HAS BEEN COMPLETED AND NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FATIGUE FAILURE OF DISTAL NCB PLATE. APPROXIMATELY 4 DAYS AFTER THE REVISION SURGERY, THE PATIENT'S CONDITION DETERIORATED AND THEY DIED. A DEFINITIVE CAUSE OF DEATH IS UNKNOWN, MULTI ORGAN FAILURE, SEPSIS, CARDIO GENIC SHOCK AND ASPIRATION PNEUMONIA, SURGICAL REPAIR OF PERIPROSTHETIC HIP FRACTURE IS SUSPECTED. DUE DILIGENCE HAS BEEN COMPLETED AND NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137306 UNKNOWN PLATE TRAUMA, PLATE HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death