BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK PSC FEMORAL STEM SCREW

    MDR report key: 9411995 · Received December 4, 2019

    Report

    Report Number
    0001825034-2019-05452
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 12, 2019
    Report Date
    April 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UPDATED: A5, B4, B5, D6, D11, G4, G7. ADDITIONAL: H1, H2, H10. D11 MEDICAL PRODUCTS: VNGD SSK PSC FMRL STEM SCREW; P/N: 183315, L/N: UNK, BMT SPLINED KNEE STM V2 14X80; P/N: 148304, L/N: 274090, BMT SPLINED KNEE STM V2 17X120; P/N: 148320, L/N: 461260, VNGD SSK PSC TIB BRG 12X79/83; P/N: 183902, L/N: 003130, SERIES A PAT STD 34 3 PEG; P/N: 184766, L/N: 458910, BMT 360 TIB TRAY 83MM; P/N: 185206, L/N: 096930, BMT 360 TIB 5.0 OFFSET ADAPTER; P/N: 185211, L/N: 691210, VNGD SSK 360 L FEM 70MM; P/N: 185286, L/N: 3782952, BMT 360 TIB SM CRUCIATE WING; P/N: 185650, L/N: 920110. 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: (B)(4). 0001825034 - 2020 - 00249.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 3 YEARS POST-IMPLANTATION DUE TO SCREW BACKING OUT OF THE FEMORAL COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD SSK PSC FMRL STEM SCREW; P/N: 183315, L/N: UNK, KNE-VANGUARD SSK-BEARINGS-UNK; P/N: UNK, L/N: UNK. 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. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO SCREW BACKING OUT OF THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202425 VANGUARD SSK PSC FEMORAL STEM SCREW PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE