BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD - BIOMET SPLINED KNEE STEM

    MDR report key: 9399669 · Received December 2, 2019

    Report

    Report Number
    0001825034-2019-05427
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    May 5, 2015
    Report Date
    April 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K121149
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. JOINT ASSIST REVIEW INDICATES PATIENT WAS DIAGNOSED WITH PERIPHERAL NEUROPATHIC PAIN RELATED TO AN ORTHOPEDIC REPLACEMENT. AT 1 YEAR VISIT PATIENT REPORTED MODERATE PAIN AND USING A CANE. AT 2 YEAR VISIT PATIENT STILL HAD PAIN AND WAS USING CRUTCHES OR A WALKER. AT 3 YEAR VISIT PATIENT CONTINUED TO HAVE PAIN, DIFFICULTY WALKING AND WAS HOUSEBOUND. OFFICIAL MEDICAL RECORDS WERE 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VANGUARD SSK FEMUR CATALOG # 185283 LOT # 3458069, VANGUARD DISTAL FEMUR AUGUMENT CATALOG # 185383 LOT # 761510, VANGUARD DISTAL FEMUR AUGMENT CATALOG # 185403 LOT # 960320, VG 360 UNIV PST FM AUG CATALOG # 185343 LOT # 144500, VG 360 UNIV PST FM AUG CATALOG # 185343 LOT # 917410, BMT SPLINED KNEE STM CATALOG # 148316 LOT # 070820, BMT OFFSET ADAPTER CATALOG # 185210 LOT # 461680, BMT TIB TRAY CATALOG # 185203 LOT # 354030, BMT OFFSET ADAPTER CATALOG # 185210 LOT # 461680, BMT TIB AUG CATALOG # 185233 LOT # 754180, VNGD SSK PSC TIB BRG CATALOG # 183890 LOT # 840400. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-05413, 0001825034-2019-05414, 0001825034-2019-05420, 0001825034-2019-05421, 0001825034-2019-05423, 0001825034-2019-05424, 0001825034-2019-05425, 0001825034-2019-05426, 0001825034-2019-05428, 0001825034-2019-05429, 0001825034-2019-05430. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION KNEE ARTHROPLASTY DUE TO INFECTION. SUBSEQUENTLY, THE PATIENT EXPERIENCED TINGLING AND NUMBNESS IN THE KNEE TWO WEEKS POSTOPERATIVELY. THE PATIENT WAS DIAGNOSED WITH PERIPHERAL NEUROPATHIC PAIN TREATED WITH GABAPENTIN, PHYSICAL THERAPY AND SLEEP MEDICATION. WITHIN THE POSTOP FOLLOW UP VISITS, THE PATIENT REPORTED DECREASING AMBULATION, INCREASED PAIN, AND THE NEED FOR ASSISTIVE DEVICE TO AMBULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193654 VANGUARD - BIOMET SPLINED KNEE STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 601210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention