BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI TIBIAL 32X6.5MM

    MDR report key: 3736690 · Received April 9, 2014

    Report

    Report Number
    0001825034-2014-02577
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    March 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PK980665
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - 102140, LOT NUMBER - 050480, EXPIRATION DATE - JUL 31, 2012, MANUFACTURE DATE ¿ JUL 18, 2007. OR THE PART/LOT INFORMATION COULD BE: CATEGORY NUMBER - 102140, LOT NUMBER - 229430, EXPIRATION DATE - JUL 31, 2012, MANUFACTURE DATE ¿ JUL 18, 2007.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BILATERAL PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2007. SUBSEQUENTLY, PATIENT ALLEGES PAIN FROM POSSIBLE DISLODGE OR SHIFT IN THE RIGHT KNEE AND PAIN IN THE LEFT KNEE AFTER A FALL IN 2013. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216099 REPICCI TIBIAL 32X6.5MM PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention