BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK 360 FEMUR L 72.5

    MDR report key: 7613542 · Received June 19, 2018

    Report

    Report Number
    0001825034-2018-03938
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    June 4, 2018
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORT(S) 0001825034 - 2018 - 03937. CONCOMITANT MEDICAL PRODUCTS: ASSOCIATED ITEM NUMBER 183890 ITEM NAME VNGD SSK PSC TIB BRG 20X71/75 LOT # 254190, ASSOCIATED ITEM NUMBER 185427 ITEM NAME VG 360 UNIV PST FM AUG 72.5X10 LOT # 085220, ASSOCIATED ITEM NUMBER 185204 ITEM NAME BMT 360 TIB TRAY 75MM LOT # 879230, ASSOCIATED ITEM NUMBER 185407 ITEM NAME VG 360 DST FM AG 72.5X10 LL/RM LOT # 792980, ASSOCIATED ITEM NUMBER 148306 ITEM NAME BMT SPLINED KNEE STM V2 16X80 LOT # 117800, ASSOCIATED ITEM NUMBER 185387 ITEM NAME VG 360 DST FM AG 72.5X10 RL/LM LOT # 645420, ASSOCIATED ITEM NUMBER 185651 ITEM NAME BMT 360 TIB LG CRUCIATE WING LOT # 974720, ASSOCIATED ITEM NUMBER 185427 ITEM NAME VG 360 UNIV PST FM AUG 72.5X10 LOT # 209630, ASSOCIATED ITEM NUMBER 185211 ITEM NAME BMT 360 TIB 5.0 OFFSET ADAPTER LOT # 380470, ASSOCIATED ITEM NUMBER 185211 ITEM NAME BMT 360 TIB 5.0 OFFSET ADAPTER LOT # 735250, ASSOCIATED ITEM NUMBER 148305 ITEM NAME BMT SPLINED KNEE STM V2 15X80 LOT # 162810. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DISLOCATED REPEATEDLY AND WAS REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458824 VNGD SSK 360 FEMUR L 72.5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 6101533

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R