BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E

    MDR report key: 8981047 · Received September 10, 2019

    Report

    Report Number
    0002648920-2019-00668
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 6, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K122765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE RETURNED PRODUCT IDENTIFIED NICKS AND GOUGES TO THE TIBIAL PLATE CONSISTENT WITH WEAR OF BEING IMPLANTED. THE ARTICULAR SURFACE ALSO HAD SIGNS OF BEING IMPLANTED IN A PATIENT. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT AS DIAGNOSED BY NUC MED SCAN. THE NUC MED SCAN IDENTIFIED ELEVATED ACCUMULATION VENTRALLY ON THE SHAFT OF THE TIBIAL PART OF THE PROSTHESIS AND THE FINDINGS ARE CONSISTEN WITH INCIPIENT DETACHMENT. DURING THE REVISION, IT WAS NOTED THAT THE TIBIAL COMPONENT WAS EASILY REMOVED WITH SOFT BONE BELOW THE SURFACE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDIAL PRODUCTS: 42500606202 - FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD RIGHT SIZE 7 ¿ 62755486; 42521400710 - ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 10 MM HEIGHT ¿ 62855821; 4711500396 - OPTIPAC 60 REFOBACIN BN CMT R - A427A03725. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 RIGHT KNEE REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO PAIN AND TIBIAL LOOSENING AS DIAGNOSED BY NUC MED SCAN. DURING THE REVISION, IT WAS NOTED THAT THE TIBIAL COMPONENT WAS EASILY REMOVED WITH SOFT BONE BELOW THE SURFACE. THE COMPONENT WAS REPLACED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778008 TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 62988620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R