BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3702549 · Received March 26, 2014

    Report

    Report Number
    1818910-2014-15265
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    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

    EXAMINATION OF THE RETURNED DEVICES FINDS NO ABNORMAL WEAR. POST RETRIEVAL DAMAGE IS NOTED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED ONE OTHER REPORT AGAINST THE 3012340 LOT CODE. A DEVICE HISTORY REVIEW WAS PERFORMED PREVIOUSLY AND IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINDER OF THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Description of Event or Problem · 1

    THE PRIMARY S-ROM MOM THA WAS CONDUCTED ON (B)(6) 2010. THE REVISION SURGERY IS SCHEDULED TO BE DONE ON (B)(6) 2014 DUE TO THE INCIDENT CAUSED BY MOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178735 PINNACLE MTL INS NEUT36IDX50OD HIP ACETABULAR INSERT/LINER KWA DEPUY INTERNATIONAL LTD. REG. # 8010379 3042350

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention