BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE MODULAR HD 28MM +0

    MDR report key: 4102141 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28510
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK871867
    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

    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 COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    HIP REVISION PERFORMED ON (B)(6) 2014. ORIGINAL OPERATION PERFORMED (B)(6) 1993. HIP WAS REVISED FOR RECURRENT DISLOCATION, STEM LOOSENED. NO OTHER NOTES AVAILABLE. PATIENT INITIALS (B)(6), NO BMI AVAILABLE. AMONG THE IMPLANTS REMOVED WAS AN ELITE MULTI-CUP 47X28 REF: 962546 LOT R01A8 (LOGGED AS 'ZTEMP' AS PRODUCT CODE IS NOT VALID IN SYNERGY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584966 ELITE MODULAR HD 28MM +0 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. G9169

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention