BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ACETABULAR SCREW

    MDR report key: 4111366 · Received September 23, 2014

    Report

    Report Number
    1818910-2014-28665
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    November 18, 2011
    Report Date
    March 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATIONS FOR THE PINN MULTIHOLE W/ GRIPTION 58MM, APEX HOLE ELIM POSITIVE STOP, AND THE SUMMIT POR TAPER SZ4 HI OFF SINCE RELEASE FOR DISTRIBUTION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE FOR THE UNKNOWN LOT CODE FOR THE SCREW. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. PATIENT WAS REVISED FOR ACETABULAR FRACTURE, LOOSE CUP, INFECTION, AND ONE BROKEN SCREW THAT WAS LEFT IN AS IT WASN¿T ABLE TO BE REMOVED. DURING THE (B)(6) 2011 OPERATION, THE STEM WAS KEPT, BUT BONE GRAFTING WAS DONE FOR THE FRACTURE AND CULTURES CAME BACK POSITIVE FOR INFECTION AND THE PATIENT WAS REIMPLANTED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589576 UNKNOWN DEPUY ACETABULAR SCREW HIP OTHER IMPLANT: SCREW HWC DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention