BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC FMRL STEM SCREW

    MDR report key: 11999725 · Received June 15, 2021

    Report

    Report Number
    0001825034-2021-01800
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D9; G3; G6; H1; H2; H3; H6. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED IT TO EXHIBIT SIGNS OF BEING USED AND THE THREADS AND SCREW HEAD ARE DAMAGED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). CONCOMITANT PRODUCTS: 161448 - VG DA360 TIB BRG ARCM 71/75X14 - UNKNOWN. REPORT SOURCE: FOREIGN COUNTRY: (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. THE PATIENT FELL AND SUPPOSEDLY THE INLAY BROKE AND SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION SURGERY. DURING THE SURGERY, IT TURNED OUT THAT THE INLAY WAS OKAY, HOWEVER, IT WAS DISCOVERED THAT THE FEMORAL SCREW HAD LOOSENED. THE CONNECTION BETWEEN THE FEMUR AND SHAFT WAS STILL STABLE AND THE FEMUR HAD GROWN FIRMLY IN PLACE AND WAS WELL GROWN INTO THE BONE. THEREFORE, THE SCREW WAS EXPLANTED AND THE REMAINING COMPONENTS WERE LEFT IN PLACE. NO FURTHER ACTIONS WERE NECESSARY AND THE SURGERY WAS COMPLETED. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896014 VNGD SSK PSC FMRL STEM SCREW PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10.