BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9/10 ULTAMET 28MM HEADS +0

    MDR report key: 3210743 · Received July 8, 2013

    Report

    Report Number
    1818910-2013-20651
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 18, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT SOLD IN US. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES DOES NOT FIND ANYTHING OUTWARD TO SUGGEST PRODUCT PROBLEM. A LINER FROM PROPER TAPER LOCK CAN BE FOUND ON THE INSERT AS WELL AS DAMAGE MOST LIKELY FROM EXTRACTION. THE FEMORAL HEAD AND INSERT ARTICULATING SURFACES DO NOT SHOW SIGNS OF ABNORMAL WEAR. THE FEMORAL STEM IS SLIGHTLY SCRATCHED PROXIMALLY, MOST LIKELY FROM EXTRACTION. BOTH MALE AND FEMALE TAPERS AND IN RELATIVELY GOOD CONDITION. MINIMAL SIGNS OF TRIBOLOGICAL MATTER FOUND. ADDITIONAL EVENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE PATIENT IS REPORTEDLY HIGHLY ACTIVE. IT IS A KNOWN WARNING AND PRECAUTION HIGH ACTIVITY LEVEL TENDS TO ADVERSELY AFFECT HIP REPLACEMENTS. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING FURTHER INVESTIGATION BY APPLIED RESEARCH AND BIOENGINEERING, IT WAS CONCLUDED THAT: ROOT CAUSE: UNDETERMINED. FROM THE INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM WHAT PRECISELY OCCURRED OR WHY. IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO IMPLANT LOOSENING THA WAS DONE WITH S-ROM MOM. AFTER IMPLANTATION, THE PATIENT HAD SWELLING IN HIP. IN THE X-RAY, IMPLANTS WERE FOUND LOOSENED DUE TO OSTEOLYSIS AROUND THE ACETABULUM AND DISTAL PART OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310541 9/10 ULTAMET 28MM HEADS +0 HEAD BALL KWA DEPUY ORTHOPAEDICS INC XPA-06

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention