BEUDAMED
    FDA Adverse Event Death Summary report: N

    3 PEG MONO GLEN SZ 3

    MDR report key: 17042737 · Received June 1, 2023

    Report

    Report Number
    0001822565-2023-01472
    Event Type
    Death
    Date Received
    June 1, 2023
    Date of Event
    April 21, 2023
    Report Date
    August 17, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00889024574205
    PMA / PMN Number
    K191814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SUDDEN CARDIAC ARREST OCCURS SUDDENLY AND OFTEN WITHOUT WARNING. IT HAPPENS WHEN AN ELECTRICAL MALFUNCTION IN THE HEART CAUSES AN IRREGULAR HEARTBEAT (ARRHYTHMIA). WITH ITS PUMPING ACTION DISRUPTED, THE HEART CAN'T PUMP BLOOD TO THE BRAIN, LUNGS, AND OTHER ORGANS. WHEN THIS OCCURS, A PERSON LOSES CONSCIOUSNESS AND HAS NO PULSE. DEATH OCCURS WITHIN MINUTES IF THE PERSON DOES NOT RECEIVE TREATMENT. SYMPTOMS THAT COULD OCCUR PRIOR TO CARDIAC ARREST INCLUDE CHEST DISCOMFORT, SHORTNESS OF BREATH, WEAKNESS, AND FAST-BEATING OR FLUTTERING HEART. THE IMMEDIATE SYMPTOMS INCLUDE SUDDEN COLLAPSE, NO PULSE, NO BREATHING, AND A LOSS OF CONSCIOUSNESS. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-01473. D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN PALACOS BONE; LOT#: UNKNOWN, ITEM#: 01.04555.440, HUMERAL HEAD 44-164MM; LOT#: 3100396, ITEM#: 01.04555.130, HUMERAL ANCHOR UNCEMENTED L; LOT#: 3112046. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) AND A HALF MONTHS AGO. APPROXIMATELY ONE (1) AND A HALF MONTHS AFTER THE INITIAL SURGERY THE PATIENT DEVELOPED CHEST PAIN WITH CXR SHOWING A MILDLY ENLARGED HEART AND UNDERWENT A SUCCESSFUL RIGHT TRANSFEMORAL HEART CATHETERIZATION. THE STENT PLACEMENT WAS AT THE PCI OF THE RCA. FIVE (5) DAYS LATER THE PATIENT REPORTED PAIN AND SWELLING IN THEIR LEFT SHOULDER THAT BEGAN ON THE SAME DAY THAT THE PATIENT UNDERWENT THE HEART CATHETERIZATION. A NEEDLE ASPIRATION WAS COMPLETED ON THE PATIENT AND SHOWED PURULENT FLUID THAT WAS CONSISTENT WITH INFECTION. THE PATIENT UNDERWENT A STAGE ONE REVISION SURGERY THAT SAME DAY AND ALL IMPLANTS WERE REMOVED WITHOUT COMPLICATION. THE PATIENT WAS SEEN APPROXIMATELY TWO (2) WEEKS LATER FOR A FOLLOW UP WITH THE SURGEON AND IT WAS NOTED THAT THE INCISION WAS HEALING WITH MINIMAL ERYTHEMA AND WAS ORDERED TO CONTINUE THE COURSE OF ANTIBIOTIC THERAPY. THE NEXT DAY THE PATIENT REPORTED INCREASED SHORTNESS OF BREATH, SUBSEQUENTLY THE PATIENT WAS FOUND SLUMPED OVER IN BED, UNRESPONSIVE AND PULSELESS, CPR WAS STARTED AND EMS FOUND IN CARDIAC ARREST. ADMITTED TO THE HOSPITAL WITH EVIDENCE OF PULMONARY CONGESTION, NO EVIDENCE OF PE OR OTHER INTRA-ABDOMINAL OR INTRAPELVIC TRAUMAS, EEG CONSISTENT WITH SEVERE ENCEPHALOPATHY TWO (2) DAYS LATER THE PATIENT EXPIRED. ALL INFORMATION THAT HAS BEEN PROVIDED TO DATE HAS BEEN REVIEWED AND THERE IS CURRENTLY NO DEFINITIVE EVIDENCE THAT ZIMMER BIOMET PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT EVENTUALLY EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314836 3 PEG MONO GLEN SZ 3 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED/EXTREMITIES KWS ZIMMER BIOMET, INC. SAGL2023 65268598 00889024574205

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| D| O