BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET GRIT BLASTED KNEE STEM 16X80

    MDR report key: 3953676 · Received July 23, 2014

    Report

    Report Number
    0001825034-2014-06378
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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: "LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY." EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE IS (OR MAY BE) NEEDED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. DEVICE IS STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY PATIENT'S DATE OF BIRTH, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, WHILE KNEELING IN THE GARDEN, PATIENT FELT A "POP' AND HAS SINCE BEEN EXPERIENCING DISCOMFORT. RADIOGRAPHS TAKEN REVEALED THE STEM LOCKING SCREW CAN BE SEEN IN THE POSTERIOR ASPECT OF THE KNEE. A REVISION HAS NOT BEEN SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431079 BIOMET GRIT BLASTED KNEE STEM 16X80 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 823140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention