BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 4171656 · Received October 14, 2014

    Report

    Report Number
    1818910-2014-29939
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    November 4, 2010
    Report Date
    September 21, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K963309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. MEDICAL RECORDS WERE REVIEWED AND FOUND THE COMPLAINT IS NOT LIKELY TO BE DEVICE RELATED. NO CONCLUSIONS CAN BE DRAWN WITH THE INFORMATION MADE AVAILABLE. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY STILL 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.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THERE WERE NO NEW ALLEGATION AND REVISION REPORTED. UPDATED PATIENT'S IDENTIFIER. ADDED PATIENT'S AGE AND LAWYER IN THE ASSOCIATED CONTACT.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. PFS ALLEGES PAIN AND LOSS OF MOBILITY. NO REVISION DATE HAS BEEN PROVIDED AT THIS TIME. THE PRIMARY OPERATIVE NOTE INDICATED A FRACTURE OCCURRED WHILE IMPLANTING THE CUP. THE PATIENT ALSO HAD A POLY LINER IMPLANTED AND NOT A METAL SO ALL IMPLANTS ARE BEING REPORTED FOR PAIN AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650383 APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT LPH DEPUY ORTHOPAEDICS INC US D10007004

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other