BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2162321 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-12256
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    November 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS A PATIENT BONE CONDITION. IT IS ALSO NOTED THAT THE ACETABULAR CUP APPEARS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE. THE INVESTIGATION WAS NOT ABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE; HOWEVER NO PRODUCT ERROR HAS BEEN VERIFIED. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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 Manufacturer Narrative · 1

    (B)(6). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS A PATIENT BONE CONDITION. IT IS ALSO NOTED THAT THE ACETABULAR CUP APPEARS POSITIONED MORE VERTICALLY THAN RECOMMENDED BY SURGICAL TECHNIQUE. THE INVESTIGATION WAS NOT ABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE; HOWEVER NO PRODUCT ERROR HAS BEEN VERIFIED. THE NEED FOR CORRECTIVE ACTION IS 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.

    Additional Manufacturer Narrative · 1

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

    (B)(4).

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN AND HETEROTOPIC OSSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX50OD 87KWA KWA DEPUY ORTHOPAEDICS INC US NA 2540676

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention NA.