BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VG 360 UNIV PST FM AUG 65X5

    MDR report key: 7918392 · Received September 28, 2018

    Report

    Report Number
    0001825034-2018-09227
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    May 16, 2014
    Report Date
    December 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (DOB): 1960. CONCOMITANT MEDICAL PRODUCTS: VANGUARD SSK 360 FEMUR LEFT CATALOG 185284 LOT 2717437, BIOMET 360 TIBIAL TRAY 63MM CATALOG 185201 LOT 371910, VANGUARD SSK TIBIAL BEARING 10S63S67 CATALOG 183860 LOT 090520, BIOMET SMOOTH KNEE STEM 14X40 CATALOG 145004 LOT 864040, BIOMET 360 2.5MM OFFSET ADAPTER CATALOG 185210 LOT 661710, VANGUARD 360 DISTAL FEMORAL AUGMENT CATALOG 185304 LOT 369520, VANGUARD 360 DISTAL FEMORAL AUGMENT CATALOG 185324 LOT 610110, VANGUARD 360 UNIVERSAL FEMORAL AUGMENT CATALOG 185344 LOT 155680, BIOMET SMOOTH KNEE STEM 10X40 CATALOG 145000 LOT 258410, BIOMET 360 TIBIAL OFFSET ADAPTER CATALOG 185211 LOT 406650, BIOMET 360 TIBIAL AUGMENT 185221 CATALOG LOT 1663550, BIOMET 360 TIBIAL AUGMENT CATALOG 185231 LOT 1934870, UNKNOWN THREE PEG PATELLA, UNKNOWN BIOMET BRAND CEMENT . (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09145, 0001825034-2018-09146, 0001825034-2018-09147, 0001825034-2018-09225, 0001825034-2018-09226, 0001825034-2018-09227, 0001825034-2018-09228, 0001825034-2018-09229, 0001825034-2018-09230, 0001825034-2018-09231, 0001825034-2018-09232, 0001825034-2018-09233, 0001825034-2018-09234, 0001825034-2018-09235.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REMOVE A NEUROMA APPROXIMATELY TWELVE MONTHS POST TOTAL KNEE ARTHROPLASTY. IT WAS STATED THAT THE EVENT WAS NOT RELATED TO THE IMPLANTED DEVICES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758394 VG 360 UNIV PST FM AUG 65X5 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 574680

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R