BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3475068 · Received November 18, 2013

    Report

    Report Number
    1818910-2013-33527
    Event Type
    Injury
    Date Received
    November 18, 2013
    Date of Event
    November 5, 2013
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTS THAT THE PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. THERE WAS FIBROUS INGROWTH ON BACK OF CUP, BUT NO BONY INGROWTH. DOI UNK - DOR (B)(6) 2013 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 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.

    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.THE INFORMATION REPORTED IN THE PREVIOUS MEDWATCH, MEDWATCH # MW-113567, WAS REPORTED IN ERROR. PLEASE DISREGARD THE INFORMATION.DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. 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.

    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. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS CUP LOOSENING. THERE WAS FIBROUS INGROWTH ON BACK OF CUP, BUT NO BONY INGROWTH.

    Description of Event or Problem · 1

    UPDATE REC¿D 01/20/2014- LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOI INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 06/17/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596635 PINNACLE SECTOR II CUP 52MM ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US DB7KW1000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention