BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR HA ACET CUP 58MM

    MDR report key: 3870441 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20894
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    LPH
    PMA / PMN Number
    PK031495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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

    INFORMATION RECEIVED FROM (B)(6). FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANTS. NO CONFIRMATION OF REVISION, OR REASON FOR REVISION, RECEIVED. IMPLANTED IN (B)(6) 2009. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. 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

    INFORMATION RECEIVED FROM (B)(6). FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANTS. NO CONFIRMATION OF REVISION, OR REASON FOR REVISION, RECEIVED. IMPLANTED IN FEBRUARY 2009. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    FORMAL CLAIM RECEIVED REGARDING PINNACLE/CORAIL HIP IMPLANTS. NO CONFIRMATION OF REVISION, OR REASON FOR REVISION, RECEIVED. IMPLANTED IN (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348202 PINN SECTOR HA ACET CUP 58MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. 1818910  C5PRJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other