BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 54MM

    MDR report key: 4013036 · Received August 15, 2014

    Report

    Report Number
    1818910-2014-25759
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK093646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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.

    Description of Event or Problem · 1

    PINNACLE CUP AND HEAD REVISION DUE TO LOOSENING OF THE CUP. SURGEON REMOVED AND REPLACED THE FOLLOWING COMPONENTS. PRODUCT CODES AND LOT NUMBERS ARE NOT AVAILABLE. COMPONENTS ARE: CERAMIC HEAD 12/14 SIZE 36 + 5, GRIPTION SECTOR PINNACLE CUP SIZE 54 AND CERAMIC LINER SIZE 36. THE COMPONENTS HAVE BEEN RETAINED BY THE PATIENT. PRIMARY PROCEDURE DETAILS ARE UNAVAILABLE; HOWEVER, THE PROCEDURE WAS AROUND 6 MONTHS AGO AND WAS BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490039 PINN SECTOR W/GRIPTION 54MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. 1818910 360254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention