BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL TRAY

    MDR report key: 13471005 · Received February 7, 2022

    Report

    Report Number
    0001825034-2022-00152
    Event Type
    Injury
    Date Received
    February 7, 2022
    Report Date
    February 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). WICKER, DANIEL I; GETMAN, GRACE W; CHRISTENSEN, KATHERINE S; CHRISTENSEN, CHRISTIAN P; FULLER, ROBERT M; (2021) A MEDIAL SUBVASTUS APPROACH FOR LATERAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: TECHNIQUE DESCRIPTION AND EARLY OUTCOME RESULTS. ARTHOPLASTY TODAY 9, PG 129-133. HTTPS://WWW.ARTHROPLASTYTODAY.ORG/ARTICLE/S2352-3441(21)00067-4/FULLTEXT. CONCOMITANT MEDICAL PRODUCTS: UNK FIXED LATERAL OXFORD FEMORAL COMPONENT: CAT# NI, LOT# NI; UNK ARTICULAR SURFACE: CAT# NI LOT# NI. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00151, 0001825034-2022-00153.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT WITHIN THE LATERAL APPROACH GROUP WAS REVISED TO A TOTAL KNEE ARTHROPLASTY DUE TO DEEP INFECTION. THE ARTICLE STUDIED OUTCOMES OF LATERAL UKAS FROM A LATERAL VERSUS MEDIAL SUBVASTUS APPROACH. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505942 UNKNOWN TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H