BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 48MM

    MDR report key: 2960778 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-02249
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    September 20, 2012
    Report Date
    January 28, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 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

    UPDATE: (B)(4) 2013 - MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT HAD DISASSOCIATED. THE CUP WAS ADDED TO THE PRODUCT PAGES. UPDATE: (B)(4) 2013 - LOT NUMBER WAS UPDATED FOR ACETABULAR CUP. VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO INDICATE DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. IT IS SUSPECTED THAT THE DEVICES WERE NOT FULLY ENGAGED WHEN FIRST IMPLANTED, LATER LEADING TO THE DISASSOCIATION NOW REPORTED. THERE IS DAMAGE IN THIS CASE HOWEVER THAT MAKES ANY CONCLUSIVE DETERMINATION AS TO THE LINER AND CUP LOCKING MECHANISMS HAVING BEEN FULLY AND PROPERLY ENGAGED DIFFICULT. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A; REV. C. A PROVIDED REVISION OPERATIVE NOTE ALSO CONFIRMS DISASSOCIATION OF THE LINER FROM THE CUP BUT DOES NOT OFFER A ROOT CAUSE. A REVIEW OF PROVIDED PATIENT X-RAYS ALSO DID NOT IDENTIFY A ROOT CAUSE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. THROUGH PRODUCT TRENDING, THE OCCURRENCE RATE FOR THIS TYPE OF FAILURE IS KNOWN TO BE VERY SMALL. 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 ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2013-12240. THIS REPORT, 1818910-2013-02249, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2013-12240.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR. DOI (B)(6) 2007 - DOR (B)(6) 2012 (RIGHT HIP). (B)(4) 2013 - MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT HAD DISASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65654 PINNACLE 300 ACET CUP 48MM CUP LPH DEPUY WARSAW BV7B81000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention