BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL STEM

    MDR report key: 13543127 · Received February 16, 2022

    Report

    Report Number
    0001822565-2022-00420
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    July 29, 2021
    Report Date
    February 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-00327, 0001822565-2022-00328, 0001822565-2022-00329, AND 0001822565-2022-00330. DAUWE, J., VANDEKERCKHOVE, B., BOUTTELGIER, R., HOLZER, L. A., DAUWE, D., VANDENNEUCKER, H. (29 JUL 2021). PATIENT-REPORTED OUTCOMES AFTER PRIMARY ROTATING HINGE TOTAL KNEE ARTHROPLASTY: A MULTI-CENTRE CLINICAL COHORT STUDY. INTERNATIONAL ORTHOPAEDICS. 45 (11), 2893-2897. HTTPS://DOI.ORG/10.1007/S00264-021-05162-7 CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT, CATALOG#: NI LOT#: NI. UNKNOWN TIBIAL TRAY, CATALOG#: NI LOT#: NI. UNKNOWN ARTICULAR SURFACE, CATALOG#: NI LOT#: NI. UNKNOWN PATELLA, CATALOG#: NI LOT#: NI. CORRESPONDENCE AUTHOR; THE ARTICLE NOTES THAT THE MAJORITY OF THE PROCEDURES WERE PERFORMED AT DELTA HOSPITAL, AUDERGHEM, BELGIUM. FOREIGN REPORT SOURCE: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS 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

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT EIGHT (8) PATIENTS EXPERIENCED A POSTOPERATIVE INFECTION FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8872 UNKNOWN FEMORAL STEM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other