BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 37.5MM NO 0

    MDR report key: 3111817 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01669
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. THE SURGEON EXPERIENCED DIFFICULTIES WITH THE SETTING OF THE CEMENT AND DUE TO STRONG FORCE APPLIED TO THE EXETER STEM WHILE IMPLANTING THE SURGEON FRACTURED THE FEMUR OF THE PATIENT. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT UNDERWENT REVISION SURGERY BUT THE EXPLANTED DEVICES AND MEDICAL RECORDS WERE NOT MADE AVAILABLE FOR REVIEW. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT DID NOT HARDENED FOR 7 MIN AND 30 SEC AND CONTINUED TOO LOW VISCOSITY. AFTER THAT THE CEMENT HARDENED TOO QUICKLY. THE CEMENT WAS INSERTED WITH HIGHER VISCOSITY THAN USUAL AND THE SURGEON IMPLANTED EXETER WITH STRONG FORCE. ACCORDING TO THE X-RAY WHICH WAS TAKEN JUST AFTER THE OP, THE TIP OF THE EXETER BROKE LATERAL FEMUR. SO, REVISION SURGERY WILL BE PERFORMED. THE CEMENT IS USUALLY STORED IN GENERAL TEMP(NOT IN REFRIGERATOR) FOR ABOUT 2 MONTHS. OP ROOM TEMP WAS NOT SPECIFIED. NO SUBSTANCES SUCH AS BLOOD, SALINE WATER AND ANTIBIOTIC WERE MIXED INTO THE CEMENT. ALL THE MONOMER AND POLYMER WERE USED. REVOLUTION MIXING SYSTEM WAS USED AND IT IS ALSO STORED IN GENERAL TEMP USUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT DID NOT HARDENED FOR 7 MIN AND 30 SEC AND CONTINUED TOO LOW VISCOSITY. AFTER THAT THE CEMENT HARDENED TOO QUICKLY. THE CEMENT WAS INSERTED WITH HIGHER VISCOSITY THAN USUAL AND THE SURGEON IMPLANTED EXETER WITH STRONG FORCE. ACCORDING TO THE X-RAY WHICH WAS TAKEN JUST AFTER THE OP, THE TIP OF THE EXETER BROKE LATERAL FEMUR. SO, REVISION SURGERY WILL BE PERFORMED. THE CEMENT IS USUALLY STORED IN GENERAL TEMP(NOT IN REFRIGERATOR) FOR ABOUT 2 MONTHS. OP ROOM TEMP WAS NOT SPECIFIED. NO SUBSTANCES SUCH AS BLOOD, SALINE WATER AND ANTIBIOTIC WERE MIXED INTO THE CEMENT. ALL THE MONOMER AND POLYMER WERE USED. REVOLUTION MIXING SYSTEM WAS USED AND IT IS ALSO STORED IN GENERAL TEMP USUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211936 EXETER V40 STEM 37.5MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3326819

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other