BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER UNICOMPARTMENTAL KNEE PRECOAT TIBIAL COMPONENT

    MDR report key: 5933361 · Received September 7, 2016

    Report

    Report Number
    0001822565-2016-02900
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    May 24, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSX
    PMA / PMN Number
    PK033363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER UNI ARTICULAR SURFACE CATALOG #: 00-5842-022-10 LOT #: 60476367, ZIMMER UNI FEMORAL COMPONENT CATALOG #: 00-5842-012-01 LOT #: 60756176. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 1 OF 2 FOR THIS PATIENT. SEE ALSO 0001822565-2017-00149. THE TIBIAL COMPONENT WAS NOT RETURNED FOR EVALUATION. INSPECTION OF THE ARTICULAR SURFACE IDENTIFIED WEAR AND GOUGES ALONG THE EDGES. WEAR AND SCRATCHES WERE ALSO NOTED ON THE CONTACT POINT OF THE FEMORAL COMPONENT ON THE CONDYLAR SURFACE. THE DAMAGE TO THE ARTICULAR SURFACE PREVENTED ACCURATE DIMENSIONAL ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT AND ARTICULAR SURFACE IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR THIS LOT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE IMMEDIATE POST-OP X-RAYS FROM THE PRIMARY SURGERY IDENTIFIED THE COMPONENTS EXHIBITED TYPICAL FIT AND ALIGNMENT. REVIEW OF THE X-RAYS IDENTIFIED THAT DECREASED MEDIAL FEMOROTIBIAL SPACE COULD BE SEEN OVER TIME, WHICH INDICATES WEAR OF THE ARTICULAR SURFACE. MEDIAL SUBLUXATION OF THE TIBIA WAS ALSO NOTED. REVIEW OF X-RAYS FROM APPROXIMATELY FOUR YEARS AFTER THE PRIMARY SURGERY CONFIRMED THE LUCENCY SUBJACENT TO THE POSTERIOR TIBIAL PLATE AND A VERTICAL SPLIT FRACTURE OF THE MEDIAL TIBIAL PLATEAU. THE IMPLANTED DEVICES WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. PER THE UNICOMPARTMENTAL KNEES PACKAGE INSERT, LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES ARE KNOWN RISKS OF THIS PROCEDURE. PER THE SURGICAL TECHNIQUE, WHEN EVALUATING THE PATIENT AND PLANNING FOR THE PROCEDURE, THE SURGEON SHOULD CONSIDER TKA IF THE PATIENT¿S ACL IS DEFICIENT. REVIEW OF THE PRE-OP MRI IMAGE CONFIRMED THAT THE PATIENT DID NOT HAVE A FUNCTIONAL ACL AT THE TIME OF THE PRIMARY SURGERY. IT APPEARS THAT PATIENT¿S DYSFUNCTIONAL ACL DID NOT PROVIDE ADEQUATE STABILITY FOR THE KNEE AND APPROPRIATE KINEMATICS, WHICH LED TO WEAR OF THE ARTICULAR SURFACE AND SUBSEQUENT LOOSENING OF THE TIBIAL COMPONENT. THE ROOT CAUSE IS CONSIDERED TO BE RELATED TO PATIENT FACTORS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584405 ZIMMER UNICOMPARTMENTAL KNEE PRECOAT TIBIAL COMPONENT KNEE PROSTHESIS HSX ZIMMER, INC. 61790561

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R