BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULZER UNIVERSAL DISTAL STEM CENTRALIZER

    MDR report key: 2082945 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01098
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES FROM THE REVISION SURGERY WERE REVIEWED; IT WAS NOTED THE STEM HAD SOME BONE INGROWTH INTO THE STEM. NO LOOSENING OF THE COMPONENTS WAS NOTED. NO COMPLICATIONS WERE NOTED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PAIN CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULZER UNIVERSAL DISTAL STEM CENTRALIZER HIP PROSTHESIS JDI ZIMMER, INC. 1404294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SULZER TOTAL HEAD, NEUTRAL NECK| SULZER NATURAL-HIP 12/14/ TAPER CEMENTED STEM| CATALOG #735235003, LOT #1414583| CATALOG #721028000, LOT #1407827