BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H SLD/APX HLE RNGLC SHL 56MM

    MDR report key: 4192490 · Received October 22, 2014

    Report

    Report Number
    0001825034-2014-08250
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, "MATERIAL SENSITIVITY REACTIONS," AND "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT TOOK PART IN MRI INVESTIGATION OF SOFT TISSUE IN TOTAL HIP ARTHROPLASTY STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED ELEVATED METAL ION LEVELS, A LIMP, PAIN, HIP FATIGUE AND BURSITIS. MRI SHOWED AN ACETABULAR CUP INCLINATION OUTSIDE THE SAFE ZONE. THE PATIENT ALSO UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. THERE HAVE BEEN NO REPORTED REVISIONS FOR EITHER SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT TOOK PART IN MRI INVESTIGATION OF SOFT TISSUE IN TOTAL HIP ARTHROPLASTY STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED ELEVATED METAL ION LEVELS, A LIMP, PAIN, AND BURSITIS. MRI SHOWED AN ACETABULAR CUP INCLINATION OUTSIDE THE SAFE ZONE. THE PATIENT ALSO UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2013. THERE HAVE BEEN NO REPORTED REVISIONS FOR EITHER SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671564 M/H SLD/APX HLE RNGLC SHL 56MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 586290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization