BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 2923889 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11233
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 14, 2012
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAUDE REPORT (B)(4) STATES THAT A PATIENT EXPERIENCED PAIN, SUDDEN INABILITY TO SIT PROPERLY OR WALK, LUCENCY, CYSTIC LESIONS, FLUID COLLECTION, OSTEOLYSIS, SOFT TISSUE DESTRUCTION, DARK FLUID, BLACK TISSUE STAINING, AND SEVERE CORROSION ON THE HEAD. PATIENT WAS DIAGNOSED WITH PARTICLE DISEASE/METAL-ON-METAL REACTION. PATIENT HAD ALSO UNDERGONE A CLOSED REDUCTION FOR DISLOCATION. IT IS NOT CLEAR WHETHER THE REPORT WAS SUBMITTED BY THE PATIENT OR AN ATTORNEY. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD FOR PRODUCT 136551000 LOT 1130640 DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PROVIDED PRODUCT/LOT COMBINATIONS SINCE THEIR 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE REOPENED AS NECESSARY.

    Description of Event or Problem · 1

    MAUDE REPORT (B)(6) STATES THAT A PATIENT EXPERIENCED PAIN, SUDDEN INABILITY TO SIT PROPERLY OR WALK, LUCENCY, CYSTIC LESIONS, FLUID COLLECTION, OSTEOLYSIS, SOFT TISSUE DESTRUCTION, DARK FLUID, BLACK TISSUE STAINING, AND SEVERE CORROSION ON THE HEAD. PATIENT WAS DIAGNOSED WITH PARTICLE DISEASE/METAL-ON-METAL REACTION. PATIENT HAD ALSO UNDERGONE A CLOSED REDUCTION FOR DISLOCATION. IT IS NOT CLEAR WHETHER THE REPORT WAS SUBMITTED BY THE PATIENT OR AN ATTORNEY. THE SUBMITTER'S NAME WAS KAREN COLLINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30349 PINNACLE MTL INS NEUT36IDX58OD ACETABULAR LINER KWA DEPUY INTL., LTD. 1198801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention