BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 11113549 · Received January 4, 2021

    Report

    Report Number
    1818910-2021-00126
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 17, 2020
    Report Date
    December 17, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232612
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT : PRODUCT CODE 960101, WORK ORDER 2073806 WAS MANUFACTURED ON 20/JAN/06. 30 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE IS ONE DEVIATION ASSOCIATED WITH THIS LOT NUMBER: DEVINT-1350. THIS DEVIATION IS RELATED TO AN ISSUE WITH THE CARTONS WHICH THE PRODUCT IS STORED IN AND THE FREQUENCY AT WHICH THE CARTON IS INSPECTED. THIS HAS NO RELATION TO THE FAILURE MODE DESCRIBED.

    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

    PATIENT UNDERWENT LEFT PRIMARY TKR IN 2006. AT THIS TIME A PRIMARY PFC RPF FEMORAL COMPONENT SIZE 5 LEFT AND A CEMENTLESS DUOFIX MBT TRAY WAS UTILISED (CAT NUMBERS AND LOT NUMBERS COULD NOT BE ESTABLISHED). PATIENT HAS DONE WELL FOR A NUMBER OF YEARS (UNDERTAKING MANUAL WORK) AND STARTED TO FEEL PAIN IN THE LAST 2 YEARS. X-RAYS SHOW A LOOSE FEMORAL COMPONENT ALONG WITH WEAR OF THE TIBIAL INSERT ON THE MEDIAL SIDE. ON OPENING THE KNEE THE FEMORAL COMPONENT WAS OBVIOUSLY LOOSE (THIS COMPONENT HAD DEBONDED AT THE IMPLANT CEMENT INTERFACE AND SHOWED SIGNED OF POLISHING WHERE THERE HAD BEEN MOVEMENT BETWEEN THE CEMENT AND THE IMPLANT). GRANULOMAS SOFT TISSUE WAS EXCISED FROM THE EXTENSOR MECHANISM, AND THERE WERE ETEOLYTIC LESIONS IN THE DISTAL FEMORAL BONE. THE DUOFIX TRAY WAS NOT OVERTLY LOOSE BUT DID COME AWAY FROM THE TIBIAL BONE WITHOUT TOO MUCH EFFORT. THE PATELLA COMPONENT WAS LEFT IN SITU. AN ATTUNE REVISION COMPONENT WAS IMPLANTED ALONG WITH BOTH FEMORAL AND TIBIAL SLEEVES. GOOD STABILITY AND FIXATION WERE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5474 PFC*SIGMA/OV/DOME PAT 3PEG,35 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0101 2073806 10603295232612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEPUY DUOFIX MBT TRAY SZ 5| PFC SIG RPF CEM FEM SZ 5 LT| PFC SIG RPF INS SZ 5 10MM| DEPUY DUOFIX MBT TRAY SZ 5| PFC SIG RPF CEM FEM SZ 5 LT| PFC SIG RPF INS SZ 5 10MM