BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONVERGE LINER

    MDR report key: 2082881 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01059
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A JOURNAL ARTICLE. EVAL SUMMARY: A PHOTO OF THE EXPLANTED LINER AND SHELL SHOWS A PORTION OF THE RIM HAS FRACTURED OFF. IT IS NOT CLEAR IF ANY OF THE PHOTOGRAPHED DAMAGE WAS CAUSED DURING EXPLANTATION. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; HOWEVER, THE ARTICLE STATED THAT X-RAYS WERE REVIEWED AND FOUND AN ABDUCTION ANGLE OF 51 DEGREES AND ANTEVERSION ANGEL OF 8 DEGREES. THE SURGICAL TECHNIQUE INSTRUCTS THE USER TO IMPLANT THE SHELL AT 45 DEGREES ABDUCTION AND 20 DEGREES ANTEVERSION. PT WAS DESCRIBED AS (B)(6) FEMALE, WITH A (B)(6). PT ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND THE RELEVANT MED HISTORY ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY AND EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED TO THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR DISLOCATION AFTER AN UNSUCCESSFUL CLOSED REDUCTION. THE RIM OF THE LINER WAS FOUND TO BE FRACTURED AND THE ENTIRE ACETABULAR COMPONENT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CONVERGE LINER HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention LOT# UNK| UNK HARRIS/GALANTE II SHELL: CATALOG #UNK,