BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/52

    MDR report key: 3110027 · Received May 13, 2013

    Report

    Report Number
    0002249697-2013-01656
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE MEDICAL REVIEW CONCLUDED THAT AN ADVERSE COMBINATION OF PATIENT-RELATED FACTORS REGARDING THE LEANING MOVEMENT, IN COMBINATION WITH THE PROCEDURE-RELATED FACTOR OF CUP POSITION IN LOW OR ABSENT ANTEVERSION WERE POSSIBLE FACTORS IN THIS REPORTED EVENT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION INCLUDING PATIENT DETAILS (HEIGHT, WEIGHT ETC), MEDICAL HISTORY AND X-RAYS CONFIRMING THE DISLOCATION ARE NEEDED IN ORDER TO COMPLETE THIS INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS SITTING ON THE STAIRS AND LEANT AROUND TO RETRIEVE SOMETHING AND THEIR HIP DISLOCATED. THE PATIENT REPORTED FEELING A DISTINCTIVE POP. THE PATIENT WAS ADMITTED TO HOSPITAL AND UNDERWENT REVISION SURGERY. REVISION OF AN MDM IMPLANT (V40 HEAD DISLOCATED OUT OF MDM LINER).

    Description of Event or Problem · 1

    PATIENT WAS SITTING ON THE STAIRS AND LEANT AROUND TO RETRIEVE SOMETHING AND THEIR HIP DISLOCATED. THE PATIENT REPORTED FEELING A DISTINCTIVE POP. THE PATIENT WAS ADMITTED TO HOSPITAL AND UNDERWENT REVISION SURGERY. REVISION OF AN MDM IMPLANT (V40 HEAD DISLOCATED OUT OF MDM LINER)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209845 RESTORATION ADM X3 INS 28/52 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 37868901

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R