BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LONGEVITY LINER

    MDR report key: 2082971 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01066
    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 SMALL CRACK AT THE RIM. THE LOCATION OF THE CRACK IN RELATION TO THE 10 DEGREE LIP CANNOT BE DETERMINED FROM THE PHOTO. NO MEASURABLE OXIDATION OF THE LINER WAS REPORTED. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED. IT WAS REPORTED THAT THE ABDUCTION ANGLE OF THE SHELL WAS 69 DEGREES. THE SURGICAL TECHNIQUE GUIDES THE USER TO IMPLANT AT 45 DEGREES. SHELL ANTEVERSION IS UNKNOWN, BUT DESCRIBED AS ANATOMIC. DETAILS OF THE STEM ORIENTATION ARE NOT KNOWN. THE PATIENT HAS A REPORTED BMI OF 34. 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. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE 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. 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 DUE TO SUBLUXATION AND CLICKING WITH WEIGHT-BEARING. SEVERAL DISLOCATIONS ARE ALSO REPORTED PRIOR TO REVISION SURGERY.

    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