BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM

    MDR report key: 2033452 · Received March 24, 2011

    Report

    Report Number
    1822565-2011-00736
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    March 10, 2004
    Report Date
    January 14, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICES ARE UNAVAILABLE, AND THE DEVICE CONDITIONS ARE UNK. THE SURGERY NOTES ARE UNAVAILABLE, AND IT IS UNK IF THE COMPONENTS WERE IMPLANTED WITH THE CORRECT ORIENTATION AND FIT AS PER THE SURGICAL TECHNIQUE. THE INSTRUMENTS USED IN THE PRIMARY SURGERY ARE UNK, AND X-RAY IMAGES ARE UNAVAILABLE. PT ACTIVITY LEVEL AS WELL AS THE REHABILITATION REGIME AND COMPLIANCE THEREOF ARE ALL UNK. BASED ON THE ABOVE INFO AND OBSERVATIONS, THE PERIPROSTHETIC FRACTURE IS MOST LIKELY DUE TO THE PT'S FALL, BUT MAY HAVE ALSO BEEN DUE TO ONE OR A COMBINATION OF THE FOLLOWING MECHANISMS: PT ACTIVITY; INCORRECT STEM/RASP RELATIONSHIP; STEM USED WAS TOO LARGE FOR FEMUR. HOWEVER THE EXACT CAUSE CANNOT BE DETERMINED. EVAL: 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR PERIPROSTHETIC FRACTURE OF THE HIP AFTER A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL STEM MEH ZIMMER, INC. 60055772

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention VERSYS HIP SYSTEM FEMORAL HEAD,| CATALOG # 00801803203, LOT # 60103635,| MANUFACTURED AT ZIMMER (B)(4)