BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY-HD CALCAR STEM W/HOLE 55X15X220 R

    MDR report key: 3910343 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05916
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    July 21, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK031693
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. IT APPEARS THE SAMPLE HAS GONE THROUGH AN EXTREME DISTRIBUTION ENVIRONMENT. PACKAGING PERFORMANCE VALIDATIONS ARE PERFORMED IN ACCORDANCE WITH INDUSTRY STANDARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. DURING THE PROCEDURE, A TEAR IN THE INNER PACKAGING OF THE FEMORAL STEM WAS NOTED. ANOTHER COMPONENT WAS USED TO COMPLETE THE PROCEDURE; HOWEVER, THERE WAS A DELAY OF THIRTY MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386340 MALLORY-HD CALCAR STEM W/HOLE 55X15X220 R PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 443040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R