BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX56OD

    MDR report key: 2142983 · Received June 23, 2011

    Report

    Report Number
    1818910-2011-11099
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 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

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    PINNACLE CLAIM SUBMISSION FORM, STICKER SHEETS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED BLOOD METAL ION LEVELS. THE CUP WAS NOTED TO BE MORE VERTICAL THAN DESIRED. OPERATIVE FINDINGS INCLUDE MILKY FLUID WITHIN THE JOINT AND A LOT OF SCAR TISSUE AROUND THE ACETABULUM. PATHOLOGY REPORTS NOTE THAT THERE WERE NO OBVIOUS AREAS OF WEAR AND TEAR ON THE CUP, HEAD AND SCREW. CLINICAL NOTES INDICATE PLASMA COBALT TO BE ELEVATED AT 78.2 MCG/L, THE CUP APPEARING TO BE IN A VERY VERTICAL POSITION, SQUEAKING AND DISCOMFORT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS REPORTED THAT THE ULTAMET LINER WAS NOT CORRECTLY POSITIONED IN THE CUP AT THE TIME OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT40IDX56OD 87KWA KWA DEPUY ORTHOPAEDICS INC US NA 3149257

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention