BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 56MM

    MDR report key: 2944949 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-02248
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    August 12, 2005
    Report Date
    September 6, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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

    THIS IS A CLINICAL PATIENT. MEDICAL RECORDS WERE OBTAINED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(4) 2012 - CLINICAL REPORT RECEIVED. CLINICAL REPORT INDICATES THE PATIENT A LOOSE ACETABULAR COMPONENT WAS FOUND UPON REVISION. UPDATE: (B)(4) 2012 - RADIOGRAPHIC REVIEWER FINDINGS RECEIVED. UPDATE: (B)(4) 2012 - THE EXISTING MDR DECISION WAS CHANGED FOR THE ACETABULAR COMPONENT. THE COMPLAINT RE-OPENED. THE ACETABULAR COMPONENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THIS 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INFECTION. MEDICAL RECORDS WERE OBTAINED. (B)(4) 2012 - CLINICAL REPORT RECEIVED. CLINICAL REPORT INDICATES THE PATIENT A LOOSE ACETABULAR COMPONENT WAS FOUND UPON REVISION. (B)(4) 2012 - RADIOGRAPHIC REVIEWER FINDINGS RECEIVED. (B)(4) 2012 - THE EXISTING MDR DECISION WAS CHANGED FOR THE ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50510 PINNACLE 100 ACET CUP 56MM CUP LPH DEPUY INTERNATIONAL YV2FL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention