BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 2113086 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-07387
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K083642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    CORRECTED: LOT #. CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: THE HEAD WAS VISUALLY INSPECTED AS PER (B)(4). THIS WILL BE FURTHER INVESTIGATED AS PART OF (B)(4) INVESTIGATION PLAN (B)(4). HOWEVER, THE PART WILL NOT BE CUT IMMEDIATELY UNTIL A SPECIFIC PROTOCOL HAS BEEN AGREED. GIVEN THIS IS A ONE OFF PART IT IS UNLIKELY THAT THE ADDITIONAL WORK WILL PROVIDE A ROOT CAUSE OF FAILURE FOR THIS SPECIFIC (B)(4). THE COMPLAINT SHALL BE CLOSED WITH AN INDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. ADDENDUM ADDED (B)(4) 2012. CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING FURTHER INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINABLE. PAIN HAS MANY CAUSES. IT IS NOT POSSIBLE TO SAY WHETHER THE PAIN WAS DUE TO THE IMPLANT ARE NOT GIVEN THE LIMITED INFORMATION. SOME TAPER CORROSION WAS IDENTIFIED. THIS IS TO BE EXPECTED FROM THE LITERATURE AS TAPER CORROSION IS REPORTED FOR A WIDE RANGE OF PRODUCTS FROM VARIOUS MANUFACTURES. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    THE PT WILL BE REVISED DUE TO PAIN AND PSEUDOTUMOR. REVISION HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD 87 KWA KWA DEPUY INTL., LTD. NA 2999125

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other