BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3142504 · Received June 3, 2013

    Report

    Report Number
    0002249697-2013-01840
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION, HISTORY REVIEW OR COMPLAINT HISTORY WAS PERFORMED AS NO DEVICES WERE RECEIVED OR IDENTIFIED. NO MEDICAL RECORDS WERE RECEIVED FOR EVALUATION. THE INVESTIGATION CONCLUDED THAT THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES AND THE RETURN OF THE DEVICES ARE NEEDED TO COMPLETE THE INVESTIGATION. THE REPORTED EVENT REGARDING DISASSOCIATION INVOLVING AN UNKNOWN POLYETHYLENE LINER WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN 36MM SEMI CONSTRAINED POLY. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE 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.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT NO: MW5029539 STATED: "VOLUN (B)(6)-2013: POLYETHYLENE LINER DISENGAGED FROM THE HIP SHELL. PATIENT RETURNED TO SURGERY."

    Description of Event or Problem · 1

    MAUDE EVENT REPORT NO: (B)(4) STATED: "(B)(6) 2013: POLYETHYLENE LINER DISENGAGED FROM THE HIP SHELL. PATIENT RETURNED TO SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245103 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWB STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention