BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE

    MDR report key: 13505993 · Received February 10, 2022

    Report

    Report Number
    0001822565-2022-00324
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    July 29, 2021
    Report Date
    February 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    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). 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 D10 - CONCOMITANT DEVICES - UNKNOWN NEXGEN ROTATING HINGE KNEE FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN ROTATING HINGE KNEE TIBIAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN PATELLA CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN FEMORAL STEM CATALOG #: NI LOT #: NI. CORRESPONDENCE AUTHOR; THE ARTICLE NOTES THAT THE MAJORITY OF THE PROCEDURES WERE PERFORMED AT DELTA HOSPITAL, AUDERGHEM, BELGIUM. REPORT SOURCE - FOREIGN: (B)(6). THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001822565-2022-00322, 0001822565-2022-00323, 0001822565-2022-00325, 0001822565-2022-00378. INSUFFICIENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO (2) PATIENTS EXPERIENCED PAIN FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669135 UNKNOWN NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other