BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 54OD

    MDR report key: 3973583 · Received August 1, 2014

    Report

    Report Number
    1818910-2014-24821
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 16, 2014
    Report Date
    September 29, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT THE REPORTED DISLOCATION. IT WAS INITIALLY REPORTED THE PATIENT HAD SCIATIC NERVE PALSY AND TWISTED, CAUSING THE PRIMARY DISLOCATION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS ALSO REPORTED THE PATIENT WAS IMPLANTED WITH A COMPETITOR ACETABULAR CUP IN CONJUNCTION WITH THE REPORTED DEPUY DEVICES. THIS IS NOT RECOMMENDED AND IS CONSIDERED OFF-LABEL USE. PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. 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. (B)(4).

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

    Description of Event or Problem · 1

    DURING THE REVISION, THE SURGEON IDENTIFIED SLIGHT CORROSION ON THE HEAD AND THE NECK, MELTING OF THE MESOGLUTEUS, AND THE NECROSIS OF THE SOFT TISSUE. THE SURGEON REPLACED THE HEAD WITH A NEW DELTA 32MM HEAD. THE LINER WAS ALSO CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451466 ULTAMET MTL INS NEUT 36MM 54OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTERNATIONAL LTD.8010379 2582375

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention