BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEG HINGE POST, SZ F 14MM 3DEG

    MDR report key: 13569802 · Received February 21, 2022

    Report

    Report Number
    0001822565-2022-00537
    Event Type
    Injury
    Date Received
    February 21, 2022
    Report Date
    April 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K070978
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS: 32855411128, SEG ART SURF SZ F 14MM 3DEG, LOT# 95002187. MDR: 0001822565-2021-03698.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION FOUND DURING INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PART REFERENCED SHOULD NOT HAVE BEEN REPORTED. THE PRODUCT IS A SUBCOMPONENT OF PREVIOUSLY REPORTED PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED. REPORTED PRODUCT AND MDR 32855411128 SEG ART SURF SZ F 14MM 3DEG LOT# 95002187, MDR: 0001822565-2021-03698.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT IS EXPERIENCING SOME ANTERIOR KNEE PAIN, WORSE WITH ACTIVITY DUR TO WEAR. A FUTURE REVISION IS BEING PLANNED, AND A REPLACEMENT CUSTOM POLY AND HINGE POST TO MATCH THE EXISTING CUSTOM IMPLANTS IS REQUIRED. NO DATE FOR THE REVISION HAS BEEN SET AT THIS TIME.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION FOUND DURING INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PART REFERENCED SHOULD NOT HAVE BEEN REPORTED. THE PRODUCT IS A SUBCOMPONENT OF PREVIOUSLY REPORTED PRODUCT. THE INITIAL REPORT SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159199 SEG HINGE POST, SZ F 14MM 3DEG PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 95002186

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other