BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSENSUS BIPOLAR HEAD, CONSENSUS BIPOLAR SYSTEM

    MDR report key: 105521 · Received July 10, 1997

    Report

    Report Number
    1645480-1997-00002
    Event Type
    Malfunction
    Date Received
    July 10, 1997
    Date of Event
    June 17, 1997
    Report Date
    July 10, 1997
    Manufacturer
    US MEDICAL PRODUCTS, INC.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL REPORT CONCERNING EVAL FOR OTHER AFFECTED UNITS AND DISTRIBUTION OF SAME: US MED PRODUCTS FEELS ASSURED THAT NO ADD'L UNITS FROM THIS LOT HAVE INCORRECT ASSEMBLY. CO WOULD SUSPECT THAT ANY SUCH CONDITION WOULD BE IMMEDIATELY DETECTED DURING SURGIAL PROCEDURES. (SEE ATTACHED) CO FEELS ASSURED THAT THIS IS AN ISOLATED INCIDENT. HISTORICALLY, NO OTHER REPORTS CONCERNING THIS SPECIFIC COMPLAINT HAVE BEEN REC'D. CO WILL CONTINUE TO FOLLOW THE ORIGINAL AFFECTED PT THROUGH INFO FEEDBACK OF OUR TAIWAN DIST. THIS SUMMARY WILL CONSTITUTE THE FINAL REPORT. SUMMARY OF US MED PRODUCTS LOT #420026 PRODUCT RECALL: A FORMAL VOLUNTARY PRODUCT RECALL WAS INITIATED BY US MED PRODUTS FOR LOT #430026. PROPER NOTIFICATION TO THE FDA WAS PERFORMED, ASSIGNED AS Z-858-7, AND HAS SINCE BEEN CONCLUDED AND THE FILE CLOSED. ALL REQUIRED AUTHORITIES IN EUROPE WERE NOTIFIED OF THE PRODUCT RECALL. AFFECTED DISTS IN EUROPE, TAIWAN, AND DOMESTIC WERE NOTIFIED. A REQUEST TO SEND APPLICABLE INVENTORY UNITS TO USMP FOR EVAL WAS MADE. A REQUEST TO SUPPLY SURGEON/PT INFO FOR ANY APPLICABLE IMPLANTED UNITS WAS MADE. ALL OUTSTNADING UNITS FROM THIS LOT HAVE BEEN RECALLED, REC'D BY US MED PRODUCTS AND EVALUATED FOR INCORRECT ASSEMBLY. NO ADD'L UNITS WERE FOUND TO HAVE INCORRECT ASSEMBLY. ALL UNITS WERE REPROCESSED (FROM ATTACHED HISTORY AND PREVIOUSLY REPORTED HISTORY). RECONCILIATION OF ALL IMPLANTED UNITS SHOWED THE FOLLOWING: 2 UNITS DOMESTIC IMPLANTATION DETERMINED TO HAVE CORRECT ASSEMBLY (SEE ATTACHED) 4 UNITS IMPLANTED IN ITALY. NO INDICATION OF INCORRECT ASSEMBLY. PRODUCT RECALL: EVAL OF PRODUCT RETURNED FROM AMPLIMEDICAL. THREE UNITS FROM BIPOLAR HEAD LOT #420026 WERE RETURNED BY AMPLIMEDICAL TO USMP. THESE UNITS WERE REC'D ON 8/07/97 PER RGA 9718302. THE UNITS WERE OPENED, AND AN INSPECTION WAS PERFORMED FOR THE ASSEMBLED CONDITION. AS OPENED, THE UNITS WERE FOUND TO BE ASSEMBLED CORRECTLY. THESE UNITS WILL BE REPACKAGED AND REPROCESSED AS LOT #420026B.

    Description of Event or Problem · 1

    DURING A BIPOLAR HIP SURGERY, IT WAS REPORTED THAT THE IMPLANTED COMPONENTS EXHIBITED MACROMOTION BETWEEN THE BIPOLAR INSERT AND THE BIPOLAR HEAD. THE COMPONENT WERE REMOVED AND NEW COMPONENTS WERE IMPLANTED. THE NEW COMPONENTS EXHIBITED THE SAME MACROMOTION. REMOVAL WAS NOT PERFORMED AND THE SURGERY WAS COMPLETED. SURGERY WAS PERFORMED IN TAIWAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSENSUS BIPOLAR HEAD, CONSENSUS BIPOLAR SYSTEM Implant BIPOLAR COMPONENT (HIP JOINT REPLACEMENT) KWY US MEDICAL PRODUCTS, INC. NA 420026

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other