BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MULTIHOLE II CUP 54MM

    MDR report key: 2926247 · Received January 23, 2013

    Report

    Report Number
    1818910-2013-11363
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    January 15, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. ADDITIONAL MEDICAL RECORDS AND PART AND LOT CODES WERE PROVIDED. THE BEGINNING OF THE REVISION OPERATIVE REPORT STATES THAT X-RAYS CONFIRMED THE ACETABULAR COMPONENT HAD MIGRATED OR ROTATED INTO A VERTICAL POSITION WHICH WAS CONFIRMED INTRAOPERATIVELY. THE SURGEON STATES THAT HE FELT THE PATIENT HAD A VERY SHALLOW ACETABULUM CONGENITALLY THAT CONTRIBUTED TO THE DISSOCIATION. THE COMPONENTS WERE CHANGED AND SECURED WITH 3 SCREWS. HE FELT HE HAD GOOD PURCHASE AT THAT TIME. THERE ARE NO OTHER SIGNIFICANT FINDINGS WITHIN THE OPERATIVE NOTES FROM EITHER SURGERY THAT WOULD SUGGEST COMPLICATIONS OR DEVIATIONS FROM THE RECOMMENDED SURGICAL PROCEDURE. FROM THE INFORMATION PROVIDED INCLUDING THE SURGEON STATEMENT REGARDING THE PATIENTS CONGENITAL, SHALLOW ACETABULAR CUP, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT WAS REVISED TO ADDRESS A LOOSE, MALPOSITIONED CUP. DOI (B)(6) 2006 - DOR (B)(6) 2013 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WAS NOT PROVIDED. OPERATIVE NOTES WERE RECEIVED WITH THE INITIAL REPORTING. THE PROVIDED RECORDS ADDRESS A PREVIOUS SURGERY AND NOT THIS (B)(6) 2013 REVISION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C; HOWEVER, NO FURTHER ADDITIONAL INFORMATION WAS OBTAINED. PER A REVIEW OF THE PROVIDED OPERATIVE REPORTS THE SURGEON STATES THAT HE FELT THE PATIENT HAD A VERY SHALLOW ACETABULUM CONGENITALLY. BASED ON THE INVESTIGATION, THE NEED FOR 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A LOOSE, MALPOSITIONED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32619 PINNACLE MULTIHOLE II CUP 54MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. AP8FM1000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention