BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3060993 · Received April 16, 2013

    Report

    Report Number
    0002249697-2013-01331
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS A LEFT UNKNOWN STRYKER HIP. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAS HAD PROBLEMS WITH HER HIP IMPLANT SINCE THE SURGERY. PATIENT REPORTS THAT HER HIP IMPLANT HAS DISLOCATED OUT OF SOCKET THREE TIMES SINCE IT WAS IMPLANTED, THE FIRST TIME ON (B)(6) 2012, THE SECOND TIME WAS (B)(6) 2013, AND THE LAST TIME WAS (B)(6) 2013. PATIENT ALSO REPORTS UNSTEADINESS WHEN ON HER FEET BECAUSE THE IMPLANT DOES NOT FEEL THAT IT IS SECURE. PATIENT ALSO STATES THAT WHEN SHE COUGHS SHE HAS PAIN IN HER GROIN AREA AND ALSO COMPLAINS OF PAIN IN HER THIGH BONE. PATIENT IS AFRAID TO DO TOO MUCH WALKING BECAUSE THE HIP DISLOCATES OUT OF SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAS HAD PROBLEMS WITH HER HIP IMPLANT SINCE THE SURGERY. PATIENT REPORTS THAT HER HIP IMPLANT HAS DISLOCATED OUT OF SOCKET THREE TIMES SINCE IT WAS IMPLANTED, THE FIRST TIME ON (B)(6) 2012, THE SECOND TIME WAS (B)(6) 2013, AND THE LAST TIME WAS (B)(6) 2013. PATIENT ALSO REPORTS UNSTEADINESS WHEN ON HER FEET BECAUSE THE IMPLANT DOES NOT FEEL THAT IT IS SECURE. PATIENT ALSO STATES THAT WHEN SHE COUGHS SHE HAS PAIN IN HER GROIN AREA AND ALSO COMPLAINS OF PAIN IN HER THIGH BONE. PATIENT IS AFRAID TO DO TOO MUCH WALKING BECAUSE THE HIP DISLOCATES OUT OF SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163590 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention