BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 3822224 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19149
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    September 27, 2013
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE FEMORAL HEAD AND LINER. PER PROCEDURE, THESE PRODUCT CODES ARE EXEMPT FROM DHR REVIEW. REVIEW OF PROVIDED MEDICAL RECORDS INDICATE THE PATIENT HAS BI-LATERAL HIP REPLACEMENTS AND WAS SCHEDULED FOR REVISION DUE TO PAIN ASSOCIATED WITH A VERTICAL CUP AND POLY-WEAR. THE CUP WAS FOUND TO BE WELL INGROWN AND NOT REVISED. NO X-RAYS WERE PROVIDED AND POSITIONING CANNOT BE COMMENTED ON. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. ADDITIONAL NARRATIVE: 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

    PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE REC'D (B)(4) 2012 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFO GIVEN. A CORRECT DOI AND DOR WAS GIVEN. AFTER REVIEW OF THE REVISION OPERATIVE NOTE IT INDICATED METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299946 PINNACLE MTL INS NEUT36IDX54OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS INC US 1863494

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention