BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BEARING

    MDR report key: 6907309 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07290
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 23, 2011
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) MEDICAL PRODUCT: UNKNOWN FEMORAL, CAT#: UNKNOWN LOT#: UNKNOWN, UNKNOWN FEMORAL, CAT#: UNKNOWN LOT#: UNKNOWN. AARON J. JOHNSON, SIRAJ A. SAYEED, QAIS NAZIRI, HARPAL S. KHANUJA, MICHAEL A. MONT ¿MINIMIZING DYNAMIC KNEE SPACER COMPLICATIONS IN INFECTED REVISION ARTHROPLASTY¿ CLIN ORTHOP RELAT RES (2012) 470:220-227. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07289, 0001825034-2017-07290.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON FURTHER ASSESSMENT, IT WAS DETERMINED THAT THIS DEVICE IN NOT A PART OF THE STAGE ONE SYSTEM USED, AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT IS EXPERIENCING DISLOCATION OF THE FEMORAL COMPONENT, PAIN AND LIMITED MOBILITY OF THE KNEE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688803 UNKNOWN BEARING PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other