BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SMOOTH STEM WITH SCREW

    MDR report key: 6989786 · Received October 31, 2017

    Report

    Report Number
    0001825034-2017-09724
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    October 10, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4)/ CONCOMITANT MEDICAL PRODUCTS: VANGUARD TIBIAL BEARING CAT#:161441, LOT#: 3511824, VANGUARD SSK FEMUR CAT#: 185283, LOT#: 3595441, VANGUARD TIBIAL TRAY CAT#: 161429, LOT#: 3535604, BIOMET SMOOTH STEM WITH SCREW CAT#: 145022, LOT#: 082350. FOREIGN- (B)(6)- THE IMPLANTING HOSPITAL IS IN (B)(6) BUT THE EVENT HAS REPORTED IN (B)(6). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2017 - 00985, 3002806535 - 2017 - 00986, 0001825034 - 2017 - 09724, 3002806535 - 2017 - 00987, 0001825034 - 2017 - 09725. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL/PINCHING SENSATION TWO YEARS FOLLOWING THE LEFT KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768945 BIOMET SMOOTH STEM WITH SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 772750

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention