BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 FEMUR L 67.5

    MDR report key: 11855330 · Received May 20, 2021

    Report

    Report Number
    0001825034-2021-01537
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 29, 2021
    Report Date
    August 17, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. X-RAY REVIEW BY THIRD PARTY HCP STATED THAT OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS NORMAL WITH EXCEPTION OF THE DISLODGED SCREW WHICH WAS NOTICED IN THE ANTERIOR JOINT. BONE QUALITY IS NORMAL. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. 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

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: BMT 360 TIB TRAY 75MM, ITEM# 185204, LOT# 342740. BMT 360 TIB LG CRUCIATE WING, ITEM# 185651, LOT# 987100. VNGD SSK PS TIB BRG 12X71/75, ITEM# 185082, LOT# 708170. BMT 360 2.5MM OFFSET ADAPTER, ITEM# 185210, LOT# 711930. BMT 360 TIB 5.0 OFFSET ADAPTER, ITEM# 185211, LOT# 268140. BMT SPLINED KNEE STM V2 15X80, ITEM# 148305, LOT# 585060. SERIES A PAT STD 34 3 PEG , ITEM# 184766, LOT# 617920. BMT SPLINED KNEE STM V2 15X80, ITEM# 148305, LOT# 881760. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO THE FEMORAL LOCK SCREW BACKING OUT. THE PATIENT FELT AND HEARD A POP IN KNEE AND WENT TO GET AN X-RAY. THE X-RAY SHOWED THAT THE FEMORAL LOCK SCREW HAD BACKED OUT AND WAS IN SOFT TISSUE IN THE ANTERIOR PORTION OF KNEE. THE SCREW WAS REMOVED AT THE REVISION. PATIENT IS DOING WELL AFTER SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753008 VNGD SSK 360 FEMUR L 67.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 6301844

    Patients

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