BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN HEAD

    MDR report key: 8389692 · Received March 5, 2019

    Report

    Report Number
    0001822565-2019-01014
    Event Type
    Death
    Date Received
    March 5, 2019
    Date of Event
    February 3, 2017
    Report Date
    November 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 04174.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF DEATH - 2018; DATE NOT PROVIDED. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: UNKNOWN LINER; CATALOG NUMBER:00875705802 LOT NUMBER:63290513 BRAND: TM MODULAR SHELL; CATALOG NUMBER:00771301200 LOT NUMBER:63346813 BRAND: TM MODULAR SHELL. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-01003, 0001822565-2019-01005, 0001822565-2019-01016. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, IT IS ALLEGED THAT THE PATIENT BECAME PARTIALLY PARALYZED AND BEGAN EXPERIENCING SIGNS OF INFECTION WITHIN ONE (1) MONTH POST-OPERATIVELY. THE HIP ALSO ALLEGEDLY "FELL APART" APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION DUE TO INFECTION APPROXIMATELY SEVEN (7) MONTHS POST IMPLANTATION OF THE TOTAL HIP ARTHROPLASTY. DARK METAL STAINED FLUID WAS NOTED AND REMOVED DURING THE REVISION. THE PATIENT EVENTUALLY PASSED AWAY, FOLLOWING CONTINUED BOUTS WITH INFECTION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182686 UNKNOWN HEAD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O| R