BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2071681 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06413
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED ITEMS AND REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED PRODUCT PROBLEMS, MANUFACTURING DEVIATIONS OR ANOMALIES. THERE IS EVIDENCE TO SUGGEST THE LINER MAY NOT HAVE BEEN ENGAGED PROPERLY WITH THE ACETABULAR CUP LEADING TO THE DAMAGE REPORTED BY THE COMPLAINANT AS CORROSION. PATIENT X-RAYS WERE REQUESTED FOR EXAMINATION. COMMUNICATION WAS RECEIVED STATING NONE WOULD BE PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INVESTIGATION, 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.

    Description of Event or Problem · 1

    THE PATIENT HAD HIP PAIN. THE SURGEON INITIALLY BELIEVED IT TO BE AN INFECTED HIP BUT DISCOVERED THE SOURCE OF THE PAIN WAS METALLOSIS. THE METAL LINER AND METAL HEAD WERE EXPLANTED AND A POLY LINER AND METAL HEAD WERE IMPLANTED. THERE APPEARS TO BE CORROSION ON THE BACKSIDE OF THE METAL LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2232497

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention