BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT28IDX50OD

    MDR report key: 1962334 · Received January 7, 2011

    Report

    Report Number
    1818910-2010-10488
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    K002883
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE PROVIDED PATIENT X-RAYS, RETURNED ITEMS AND REVIEW OF THE DEVICE HISTORY DID NOT REVEAL ANY RELATED PRODUCT PROBLEMS, MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. 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.

    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

    ADDITIONAL NARRATIVE: (B)(4). THE PROVIDED X-RAY IMAGES AND DEVICES WERE EXAMINED AND NOTHING OUTWARD NOTED TO SUGGEST PRODUCT NON-CONFORMANCE. A REVIEW OF DEVICE HISTORY RECORDS FOUND NO RELATED DEVIATIONS OR ANOMALIES THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNK, IT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY IN (B)(6) 2006.

    Description of Event or Problem · 1

    UPDATE REC'D 12/23/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, UPON REVISION BLACK STAINED TISSUE AND METALLOSIS WERE ENCOUNTERED. ALSO NOTED IN THE MEDICAL RECORDS, THE PATIENT HAD ELEVATED COBALT AND CHROMIUM LEVELS. AT THIS TIME AN UNKNOWN DEPUY STEM IS BEING ADDED TO THE COMPLAINT AND REPORTED. THE COMPLAINT WAS UPDATED ON: 01/18/2015.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS PAIN AND INFLAMMATION. IT WAS FOUND THAT THE TISSUE WAS GRAY, AND THE FLUID WAS MILKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT28IDX50OD 87KWA KWA DEPUY INTL LTD NA 2048434

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention