BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM

    MDR report key: 2133533 · Received June 15, 2011

    Report

    Report Number
    1822565-2011-01415
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 10, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: X-RAYS OF THE PT POST OP WERE NOT AVAILABLE FOR REVIEW. THE REVISION NOTES WERE REVIEWED REVEALING THAT THE PT HAD HETEROTOPIC OSSIFICATION OF THE RIGHT HIP JOINT, PROXIMAL FEMUR MALUNION, AND SEPTIC LOOSENING. X-RAYS OF THE PT BEFORE AND AFTER THE REVISION WERE NOT RETURNED FOR REVIEW. 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 RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM FEMORAL STEM LPH ZIMMER INC. 65904100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CATALOG #00999801845, LOT #60572409| ZMR HIP SYSTEM FEMORAL BODY