BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMARP STB TB IN 5 12.5

    MDR report key: 7086778 · Received December 6, 2017

    Report

    Report Number
    1818910-2017-50851
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    NJL
    UDI-DI
    10603295241393
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY :NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    OVER THE SUMMER THE PATIENT DESCRIBED A LOUD POPPING NOISE FROM HIS KNEE WHILE HE WAS WORKING ON HIS DECK. THE NOISE WAS PROCEEDED BY INSTABILITY AND ANTERIOR SUBLUXATION OF THE KNEE JOINT. THE PATIENT'S IMPLANTS APPEARED TO BE WELL FIXED ON X-RAY, BUT DUE TO THE PAIN AND INSTABILITY, SURGERY WAS REQUIRED. UPON ENTRY INTO THE JOINT SPACE THE IT WAS DISCOVERED THAT THE STEM OF THE RP POLY HAD BROKEN OFF AND WAS FLOATING IN THE JOINT. AFTER THE POLY WAS REMOVED A NEW TRIAL POLY (12.5 MM) WAS INSERTED. THE JOINT SPACE WAS EXTREMELY LOOSE IN FLEXION AND AFTER TRAILING UP TO A 20 MM POLY, THE SURGEON DETERMINED THE POSTERIOR LATERAL CORNER OF THE LATERAL COLLATERAL LIGAMENT WAS DAMAGED AND THAT THE PATIENT NEEDED TO BE REVISED TO A TC3 COMPONENT. WE PROCEEDED WITH THE OPERATION AND FELT THAT STABILITY HAD BEEN ATTAINED WITH THE NEW IMPLANTS. DR. (B)(6) EXAMINED THE BROKEN POLY INSERT AND DETERMINED THAT IT DID NOT BREAK CLEANLY. HE FELT IT FATIGUED OVER SEVERAL YEARS. HE EXPLAINED THAT THE PATIENT'S HISTORY OF HTO AND TKA LEAD HIM TO BELIEVE THE PATIENT WAS NOT APPROPRIATELY BALANCED AT THE TIME OF HIS ORIGINAL KNEE REPLACEMENT AND DUE TO THE INSUFFICIENT LIGAMENT, THAT THE POLY WAS LIFTING OVERTIME THE PATIENT WENT INTO DEEP FLEXION. THEREBY CAUSING FATIGUE OF THE POST OF THE POLY AS IT SUBLIMED TO THE ANTERIOR PORTION OF THE TIBIAL TRAY. OVER TIME THE POLY FINALLY GAVE WAY WHICH WAS THE POPPING NOISE THE PATIENT HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867022 PFC SIGMARP STB TB IN 5 12.5 KNEE TIBIAL INSERT NJL DEPUY INTERNATIONAL LTD - 8010379 10603295241393

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention