BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC INTLK FMRL 60 LT

    MDR report key: 13367940 · Received January 27, 2022

    Report

    Report Number
    0001825034-2022-00209
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    January 17, 2022
    Report Date
    April 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBV
    PMA / PMN Number
    K042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: SERIES A PAT STD 31 3 PEG CATALOG # 184764 LOT # 903730. BIOMET ILOK STEM TIB TRAY 67MM CATALOG # 141512 LOT # 335530. BMT SPLINED KNEE STM 16X80 CATALOG # 141616 LOT # 665450. VNGD SSKPSC TIB BRG S 14X63/67 CATALOG # 183824 LOT # 797410. BMT SPLINED KNEE STM 14X80 CATALOG # 141614 LOT # 345850. REFOBACIN REVISION 1X40G CATALOG # 3011630001 LOT # 911BAE2503. REFOBACIN REVISION 1X40G CATALOG # 3011630001 LOT # 926AAF2204. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE PROVIDED PHOTO FOUND THE FEMORAL COMPONENT FRACTURED. THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWELVE YEARS POST IMPLANTATION DUE TO FRACTURED FEMORAL PROSTHESIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102113 VNGD SSK PSC INTLK FMRL 60 LT PROSTHESIS KNEE MBV ZIMMER BIOMET, INC. N/A 425370

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention| H SEE H10 NARRATIVE.