BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPRESS SPINDLE

    MDR report key: 8730382 · Received June 25, 2019

    Report

    Report Number
    0001825034-2019-02705
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF 0001825034-2019-03223.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS REPORT IS A DUPLICATE OF 0001825034-2019-03223.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS MODULAR TIBIAL BASE CATALOG # 150421 LOT # 114620, COMPRESS SEGMENTAL ANCHOR PLUG CATALOG # 178412 LOT # 721820, REFOBACIN BONE CEMENT CATALOG # UNKNOWN LOT # 745EAH2108, OSS 3CM OSSEOTI PROX TIB SLV CATALOG # 151816 LOT # 592130, NEXGEN CR-FLEX BEARING CATALOG # UNKNOWN LOT # 398650. 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: 0001825034-2019-02699, 0001825034-2019-02704. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED PAIN AND WAS EXPERIENCING LOOSENING POST OPERATIVE. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523849 UNKNOWN COMPRESS SPINDLE PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention