BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 28MM 46OD

    MDR report key: 3972142 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24531
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK023786
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED FEMORAL HEAD AND METAL INSERT FINDS EVIDENCE TO SUPPORT THE REPORTED DISLOCATION. SIGNS OF EITHER SUBLUXATION OR HEAVY EXTRACTION DAMAGE ARE PRESENT ON THE EDGE OF THE ACETABULAR INSERT. THE FEMORAL HEAD HAS WEAR INDICATING IT CAME INTO DIRECT CONTACT WITH THE ACETABULAR CUP. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. NO ADDITIONAL INVESTIGATIVE INPUTS OR EVENT INFORMATION WAS PROVIDED TO CUSTOMER QUALITY. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO ANOMALIES ATTRIBUTED TO MOM DEVELOPED AFTER THE INITIAL THA PERFORMED ON (B)(6) 2007. AFTER THE INITIAL SURGERY, THE PATIENT HAD BEEN SUFFERING MILD PAIN FOR LONG TIME, AND ALSO HAD A TENDENCY OF GATHERING ABNORMAL AMOUNT OF JOINT FLUID. FURTHERMORE, AFTER HAVING THE DISLOCATION BY FALLING DOWN, HER JOINT HAS BECOME DISLOCATED ON MULTIPLE OCCASIONS. DURING THE SURGERY, THE SURGEON FOUND THAT THE PSEUDOTUMORS WERE THINLY SPREADING OVER THE WIDE AREA. THE PSEUDOTUMORS WERE REMOVED, AND THE SIZE OF THE METAL HEAD WAS CHANGED FROM 28MM + 8.5 TO 28MM + 12.0. THE METAL LINER WAS ALSO CHANGED TO POLY-LINER. THE STEM AND CUP WERE NOT REMOVED BECAUSE THEY DID NOT SHOW ANY LOOSENING, AND THE SURGEON CONCLUDED THAT IT WOULD BE FAR MORE RISKY TO REMOVE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447487 ULTAMET MTL INS NEUT 28MM 46OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTERNATIONAL LTD. 8010379 2184204

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention