BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 56MM

    MDR report key: 4843134 · Received June 14, 2015

    Report

    Report Number
    1818910-2015-23440
    Event Type
    Injury
    Date Received
    June 14, 2015
    Date of Event
    May 19, 2015
    Report Date
    June 10, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING ADDITIONAL EVENT INFORMATION. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    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. (B)(4).

    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. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. 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.

    Description of Event or Problem · 1

    UPDATE RECEIVED FROM CLINICAL ON 11/2/2015. IT HAS BEEN REPORTED THAT THE PATIENT HAD ALSO SUFFERED FROM PAIN. CIRCUMFERENTIAL RADIOLUCENCY AROUND THE ACETABULUM WAS NOTED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THAT PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING.

    Description of Event or Problem · 1

    UPDATE REC'D 11/23/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, UPON REVISION THE PATIENT WAS FOUND TO HAVE A SYNOVIAL REACTION. ALSO NOTED, THE PATIENT HAD A SCREW REVISED FOR CUP LOOSENING. AT THIS TIME THE SCREW IS BEING ADDED TO THE COMPLAINT AND REPORTED.THE COMPLAINT WAS UPDATED ON: 12/10/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387131 PINNACLE SECTOR II CUP 56MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. 235137

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention