BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET TIB TRAY 5.0MM ADAPTOR

    MDR report key: 10819485 · Received November 10, 2020

    Report

    Report Number
    0001825034-2020-04073
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    June 20, 2017
    Report Date
    March 22, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304001008
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. D6: EXPLANT DATE - DECEMBER 2020. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE INFECTION WAS DETERMINED TO NOT BE DEVICE RELATED. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE LOOSENING. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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 A KNEE REVISION. ALL COMPONENTS WERE REMOVED AND HER KNEE WAS FUSED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: EVENT DATE - (B)(6) 2017; 183302 - FEMORAL COMPONENT - 985620; 185026 - BEARING - 437850; 141481 - TIBIAL TRAY - 305890; 184762 - PATELLA - 377690; 141610 - STEM - 172080; 141612 - STEM - 206110; 141741 - TIBIAL BLOCK - 117450; 141741 - TIBIAL BLOCK - 705130; 184122 - FEMORAL AUGMENT - 102230; 184102 - FEMORAL AUGMENT - 262840. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-04067, 0001825034-2020-04068, 0001825034-2020-04069, 0001825034-2020-04070, 0001825034-2020-04071, 0001825034-2020-04072, 0001825034-2020-04074, 0001825034-2020-04075, 0001825034-2020-04076, 0001825034-2020-04077.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 10 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE ALL DEVICES WERE REMOVED AND PATIENT WAS WITHOUT HARDWARE FOR APPROXIMATELY ONE YEAR TO CLEAR INFECTION. THE PATIENT WAS REIMPLANTED APPROXIMATELY 3 YEARS AGO. PATIENT STATES SHE HAS HAD A (B)(6) INFECTION FOR THE PAST 3 YEARS. SHE NOTED THAT SHE HAS TO BE REVISED AGAIN AND IS POSSIBLY LOOKING AT AN AMPUTATION. SHE ALSO RELAYED THAT THE EXTRA LONG STEMS IMPLANTED ARE ROCKING IN HER BONES AND CAUSING DAMAGE TO HER BONES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281227 OFFSET TIB TRAY 5.0MM ADAPTOR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 019240 00880304001008

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R