BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER VIVACIT-E LINER

    MDR report key: 3032233 · Received March 29, 2013

    Report

    Report Number
    1822565-2013-00563
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES WERE RETURNED. AFTER IMPLANTATION OF COMPONENTS, STABILITY WAS NOTED TO BE EXCELLENT. NOTES FROM THE PT'S DISLOCATION STATE THAT THE PT WAS SITTING WHEN HE HEARD A POP IN HIS HIP. NO X-RAYS WERE RETURNED FOR REVIEW TO ASSESS THE COMPONENT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. IT IS UNK IF THE PT ABIDED BY THE RECOMMENDED POST-OP PRECAUTIONS WHILE SITTING DOWN, WHICH LED TO THE DISLOCATION. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAD A HIP REDUCTION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131167 UNKNOWN ZIMMER VIVACIT-E LINER HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention LOT #UNK| ZIMMER CLUSTER 60MM CONTINUUM SHELL: CATALOG #UNK,