BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MINISCAL TRAY

    MDR report key: 3914845 · Received July 4, 2014

    Report

    Report Number
    1818910-2014-22712
    Event Type
    Injury
    Date Received
    July 4, 2014
    Date of Event
    June 19, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    TWO X-RAYS WERE RETURNED, HOWEVER NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODES WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY

    Description of Event or Problem · 1

    REVISION KNEE REPLACEMENT: PERFORMED ON (B)(6) 2014. PRIMARY: TOTAL KNEE REPLACEMENT PERFORMED APPROXIMATELY 24 YEARS AGO, HOSPITAL AND SURGEON UNKNOWN, A CEMENTLESS LCS MENISCAL BEARING WAS USED. PATIENT PRESENTED WITH PAIN AROUND THE KNEE WITH SUSPECTED LOOSE COMPONENTS. ON OPENING THE KNEE DAMAGE WAS NOTED TO BOTH POLY BEARINGS WITH POLY DEBRIS FOUND IN JOINTS AND POSTERIOR CONJULAR BONE LOSS. COMPONENTS REMOVED; NO CODES OR LOT NUMBERS AVAILABLE. L X LCS PARACOTE FEMUR, 2 X MENISCAL BEARINGS AND MENISCAL TRAY AND REPLACED WITH PFCPC3. PHOTOS OF X-RAYS AVAILABLE. PATIENT DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392946 UNKNOWN MINISCAL TRAY KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention