BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM DISTAL CENTRALIZER

    MDR report key: 2181112 · Received July 22, 2011

    Report

    Report Number
    1822565-2011-01694
    Event Type
    Injury
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    KWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE OPERATIVE NOTES WERE PROVIDED WHICH TALK ABOUT SEVERE OSTEOARTHRITIS OF LEFT HIP. THE X-RAYS DID NOT INDICATE ANY COMPLICATIONS. IT APPEARS THAT THE LEFT HIP HEAD CENTRE IS LOCATED DISTAL TO THE RIGHT HIP HEAD CENTER. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM DISTAL CENTRALIZER KWL ZIMMER INC 61000267

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #60953023| ALL MANUFACTURED BY ZIMMER B.V. PONCE, PUERTO RICO| CATALOG #00630505028, LOT #60853613| VERSYS FEMORAL HEAD, CATALOG #00801802802| LOT #60975924| VERSYS TRILOGY LONGEVITY CROSSLINKED POLY LINER| TRILOGY SHELL WITH CLUSTER HOLES| CATALOG #00620005222, LOT #60987947| BONE SCREW SELF-TAPPING, CATALOG #00625006530| VERSYS HERITAGE NECK TAPER, CATALOG #0078571300| BONE SCREW SELF-TAPPING, CATALOG #00625006540| LOT #60945761| LOT #60903693