BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3172586 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19025
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910 
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    THE 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 SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A 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

    PRODUCT COMPLAINT # (B)(4). 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). 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

    PATIENT WAS REVISED TO ADDRESS PAIN AND DISCOMFORT. UPDATE: (B)(6) 2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ACETABULAR CUP LOOSENING AND METALLOSIS. A CUP IS NOW BEING REPORTED TO ADDRESS THE LOOSENING.

    Description of Event or Problem · 1

    PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND ELEVATED METAL ION LEVELS. AFTER REVIEW OF MEDICAL RECORDS, IT WAS NOTED THAT CUP IS WELL FIXED. DOI: (B)(6) 2002. DOR: (B)(6) 2013 . RIGHT HIP.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, IT IS INDICATED THAT THE CUP IS WELL FIXED. THERE WAS NO REPORTED LOOSENING. MDR DECISION FOR CUP CHANGED TO NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274108 PINNACLE SECTOR II CUP 52MM ACETABULAR SHELL LPH DEPUY ORTHOPAEDICS, INC. 1818910  WL3DP1002

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention