BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LONGEVITY LINER

    MDR report key: 2082963 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01067
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A JOURNAL ARTICLE. EVALUATION SUMMARY: A PHOTO OF THE EXPLANTED LINER WAS RECEIVED AND IT SHOWS A PORTION OF THE RIM HAS FRACTURED OFF. NO MEASURABLE OXIDATION OF THE LINER WAS REPORTED. SURGICAL NOTES WERE NOT PROVIDED. A PHOTO OF AN X-RAY WAS PROVIDED. IT SHOWS AT LEAST THREE SHELL FIXATION SCREWS. THE HEAD APPEARS TO BE PARTIALLY DISLOCATED FROM THE SHELL. IT WAS REPORTED THAT THE ABDUCTION ANGLE OF THE SHELL WAS 51 DEGREES INITIALLY. OVER TIME, THE ANGLE INCREASED TO 62 DEGREES AS SHOWN IN THE X-RAY AND LATER TO 68 DEGREES. THE SURGICAL TECHNIQUE GUIDES THE USER TO IMPLANT AT 45 DEGREES. SHELL ANTEVERSION IS DESCRIBED AS NORMAL. RELEVANT MEDICAL HISTORY PRIOR TO THE THA INCLUDED ACETABULAR FRACTURE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR SUBLUXATION APPROXIMATELY 23 MONTHS AFTER IMPLANTATION. AT THE REVISION, THE LINER WAS FOUND FRAGMENTED IN THE SUPERIOR QUADRANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention