BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F

    MDR report key: 7996794 · Received October 23, 2018

    Report

    Report Number
    0002648920-2018-00757
    Event Type
    Death
    Date Received
    October 23, 2018
    Date of Event
    October 2, 2018
    Report Date
    April 9, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K122765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE RADIOGRAPHIC ASSESSMENT IDENTIFIED NO SIGNIFICANT FINDINGS. PER THE PERSONA KNEE SYSTEM PACKAGE INSERT (87-6204-055-23, REV. A), PAIN AND SWELLING ARE KNOWN POTENTIAL ADVERSE EFFECTS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 7, ITEM # 42500606202, LOT # 62689656. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 11 MM HEIGHT, ITEM # 42521400711, LOT # 62604173. ALL POLY PATELLA CEMENTED 32 MM DIAMETER, ITEM # 42540000032, LOT # 62929021. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 3007963827-2018-00182, 0002648920-2018-00758, 0002648920-2018-00759. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED THAT A PATIENT HAD INITIAL KNEE SURGERY AND HAS REPORTED HAVING TWISTED HIS KNEE WHILE DESCENDING STAIRS CAUSING PAIN AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837202 PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE F PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63041084

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention