BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 11968781 · Received June 9, 2021

    Report

    Report Number
    0001822565-2021-01565
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 21, 2021
    Report Date
    July 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024211131
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS NOTED THAT THE PATIENT WAS HAVING PATELLAR PAIN DUE TO PRESSURE ON THEIR NATIVE PATELLA. THIS REQUIRED THE PATIENT TO UNDERGO A PATELLAR RESURFACING PROCEDURE DURING WHICH THE POLY WAS REVISED FIVE YEARS STATUS INDEX PROCEDURE. THERE WAS NO INDICATION OR ALLEGATION OF FAILURE OR MALFUNCTION RELATED TO THE POLY AND THE POLY WAS NOT IDENTIFIED AS A CONTRIBUTING FACTOR TO THE PAIN BEING EXPERIENCED BY THE PATELLAR PAIN. THEREFORE, THIS REVISION WAS RELATED TO DISEASE PROGRESSION OF THE PATELLA. 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

    FROM ADDITIONAL INFORMATION RECEIVED, THE PATELLA RESURFACING SURGERY WAS PERFORMED DUE TO PATELLA PAIN FROM PRESSURE ON A PREVIOUSLY UN-RESURFACED PATELLA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: LPS-FLEX GSF OPT SZ E-R, CATALOG #: 00-5764-015-52, LOT #: 63099325. ST PRC TIB PLT SIZE 3, CATALOG #: 00-5980-037-01, LOT #: 62992024. STEM IMPLANT 15MMDX75MM, CATALOG #: 00-5988-012-15, LOT #: 63260059. UNKNOWN BONE CEMENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR AN ARTICULAR SURFACE PROSTHESIS EXCHANGE, SYNOVECTOMY AND PATELLA RESURFACING. 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
    865729 NEXGEN LPS-FLEX ARTICULAR SURFACE PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 63214680 00889024211131

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R