BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD BIOMET OFFSET ADAPTER

    MDR report key: 9399670 · Received December 2, 2019

    Report

    Report Number
    0001825034-2019-05428
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    May 5, 2015
    Report Date
    April 21, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K093293
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD SSK FEMUR CATALOG # 185283 LOT # 3458069, VANGUARD DISTAL FEMUR AUGUMENT CATALOG # 185383 LOT # 761510, VANGUARD DISTAL FEMUR AUGUMENT 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 SPLINED KNEE STM CATALOG # 148318 LOT # 601210, BMT TIB AUG CATALOG # 185233 LOT # 754180, VNGD SSK PSC TIB BRG CATALOG # 183890 LOT # 840400. H3: 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, 0001825034-2019-05427, 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
    1193677 VANGUARD BIOMET OFFSET ADAPTER PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 461680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention