BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PRECOAT STEMMED TIBIAL PLATE SIZE 7

    MDR report key: 6248379 · Received January 12, 2017

    Report

    Report Number
    0001822565-2017-00176
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    September 5, 2016
    Report Date
    March 3, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: NEXGEN PRECOAT CR-FLEX FEMORAL SIZE G-RT, CATALOG NUMBER: 00595001702, LOT NUMBER: NI; ITEM NAME: NEXGEN MOLDED CR-FLEX ARTICULAR SURFACE BLUE 10 MM, CATALOG NUMBER: 00597005010, LOT NUMBER: NI.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE BELONGED TO A DIFFERENT LOCATION. PLEASE SEE REPORT 0002648920-2017-00166 .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN UNKNOWN GENITOURINARY/RENAL COMPLICATION APPROXIMATELY 9 MONTHS AFTER DATE IMPLANTED. IT IS UNCERTAIN IF THE EVENT IS DEVICE RELATED. THE OUTCOME IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28690 NEXGEN PRECOAT STEMMED TIBIAL PLATE SIZE 7 PROTHESIS, KNEE JWH ZIMMER, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R