BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 9860554 · Received March 20, 2020

    Report

    Report Number
    0001825034-2020-01241
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    November 22, 2019
    Report Date
    May 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#:141235; BIOMET CC CRUCIATE TRAY 79MM MM; LOT#:UNKNOWN, ITEM#:183666; VNGD PS TIB BRG 16X79/83MM MM; LOT#:UNKNOWN, ITEM#:184793;  SERIES A ASYMMETRIC PAT 34X8.5; LOT#:UNKNOWN, ITEM#:UNKNOWN; UNKNOWN CEMENT; LOT#:UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS PLACED ON A 10 DAY HOLD AND RELEASED TO THE PATIENT. 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: 0001825034-2020-01237, 0001825034-2020-01238, 0001825034-2020-01239, 0001825034-2020-01240. MW5092836

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TWO YEARS POST-OP DUE TO PAIN, INSTABILITY, LOOSENING AND IMPLANT WEAR. OFFICE NOTES INDICATED THE LOOSENING MAY HAVE BEEN CAUSED BY A METAL ALLERGY. ADDITIONALLY, THE PATIENT IS AMBULATORY WITH A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322594 UNKNOWN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R