BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LONGEVITY LINER

    MDR report key: 2082943 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01085
    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

    INFO WAS RECEIVED FROM A JOURNAL ARTICLE. EVAL SUMMARY: NO MEASURABLE OXIDATION OF THE LINER WAS REPORTED. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE PT WAS DESCRIBED AS FEMALE, (B)(6). RELEVANT MEDICAL HISTORY REPORTED WAS A VALGUS ARTHRITIC DYSPLASTIC RIGHT HIP. PT 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 UNK. ADHERENCE TO REHAB PROTOCOL IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE FOR THE REPORTED SUBLUXATION AND REVISION 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 SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT 22 MONTHS AFTER REVISION SURGERY, THE PT NOTED SUBLUXATION WITH WEIGHT-BEARING AND UNDERWENT REVISION SURGERY. DURING THE REVISION, FRAGMENTATION OF THE LINER WAS NOTED AT 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