BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9/10ULTAMET36MMHEADS+6

    MDR report key: 3052639 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15247
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO CONFIRM THE FEMORAL HEAD CONTACTED THE ACETABULAR COMPONENT. THE ACETABULAR COMPONENT WAS HOWEVER NOT RETURNED FOR EVALUATION. REVIEW OF PROVIDED PRE-REVISION X-RAYS CONFIRMS DISLOCATION OF THE FEMORAL HEAD AND ACETABULAR COMPONENT. EVIDENCE FOUND ON THE LINER INDICATES EDGE LOADING. THE PATIENT IS A REPORTED (B)(6) MALE WITH LOW ACTIVITY LEVEL. REVIEW OF PROVIDED PATIENT UNDATED X-RAYS FINDS OBVIOUS DISLOCATION. THE PATIENT HAS BEEN CABLED, INDICATING PREVIOUS PERI-PROSTHETIC FRACTURE. IT CAN BE SEEN THE COLLARED STEM IS NOT SEATED ON THE CALCAR PLANE. DECREASED RADIOGRAPHIC DENSITY FOUND UPON REVIEW. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBERS 962713000 AND 121887352 LOT NUMBERS 2543603 AND 2404861 FOUND NO ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT SOLD IN US. NO MDR REQUIRED. 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

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

    Description of Event or Problem · 1

    UPDATE (B)(6) 2013 PRODUCT/LOT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO DISLOCATION AND METALLOSIS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155375 9/10ULTAMET36MMHEADS+6 HEAD BALL KWA DEPUY ORTHOPAEDICS 2543603

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention