BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD CR ILOK FEMORAL-RT 65

    MDR report key: 4150467 · Received October 7, 2014

    Report

    Report Number
    0001825034-2014-07976
    Event Type
    Injury
    Date Received
    October 7, 2014
    Report Date
    November 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH: CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿MATERIAL SENSITIVITY REACTIONS¿ AND ¿POSTOPERATIVE PAIN¿. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-07976 / 08700).

    Description of Event or Problem · 1

    PATIENT REPORTED TO HAVE UNDERGONE RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN (B)(6) 2011 AND LEFT TOTAL KNEE ARTHROPLASTY ONE WEEK LATER. THE PATIENT ALLEGES PAIN, INFLAMMATION AND "TIGHTNESS" IN BOTH JOINTS AND IS SEEKING A SECOND OPINION FROM ANOTHER SURGEON. THERE HAS BEEN NO REVISION PROCEDURE REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2011 AND A TOTAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT ALLEGES PAIN, INFLAMMATION AND TIGHTNESS IN BOTH JOINTS. ADDITIONALLY, THE PATIENT FELL ONTO HER KNEES ON (B)(6) 2014. AN EXAMINATION TOOK PLACE THAT DETERMINED THERE WAS NO EVIDENCE OF IMPLANT COMPLICATIONS OR FRACTURE. A SMALL RIGHT KNEE EFFUSION WAS REPORTED ON THE PATIENT'S MEDICAL RECORDS. THERE HAVE BEEN NO REVISION PROCEDURES REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628449 VANGUARD CR ILOK FEMORAL-RT 65 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 137210

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R