BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC TIB BRG

    MDR report key: 6960826 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-08782
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    February 14, 2018
    Report Date
    May 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ATTRIBUTED TO POST SURGICAL TRAUMA CAUSED BY PATIENT FALL. IT IS UNKNOWN IF THE FALL WAS CAUSED BY IMPLANT FAILURE. 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 185651 BMT 360 TIB LG CRUCIATE WING LOT # 054530, 148166 BMT GB KNEE STM 16X80 LOT # 162770, 185204 BMT 360 TIB TRAY 75 MM LOT # 284720, 185430 VG 360 UNIV PST FM AUG 80X10 LOT # 838240, 185234 BMT 360 TIB AUG 75 X 10 MM LOT # 640120, 185310 VG 360 DST FM AG 80X5 RL/LM LOT # 524000, 185270 VNGD SSK 360 R FEM 80 MM LOT # 3873978, 185430 VG 360 UNIV PST FM AUG 80X10 LOT # 838240, 185234 BMT 360 TIB AUG 75 X 10 MM LOT # 371260, 185330 VG 360 DST FM AG 80X5 LL/RM LOT # 092150, 148168 BMT GB KNEE STM 18X80 LOT # 336080. 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 AS NO WERE TRENDS IDENTIFIED. 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 THAT THE PATIENT IS SCHEDULED FOR A REVISION SURGERY FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED A FALL THAT CAUSED A GAP IN THE PATIENT'S SOFT TISSUE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742446 VNGD SSK PSC TIB BRG PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 017290

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O| R