BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FL

    MDR report key: 96375 · Received June 3, 1997

    Report

    Report Number
    2029012-1997-00092
    Event Type
    Death
    Date Received
    June 3, 1997
    Date of Event
    May 9, 1997
    Report Date
    June 3, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    LMN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED INVOLVING PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER GRANULES THAT WERE USED TO REPAIR A SYNOVIAL NONUNION OF THE LEFT PROXIMAL HUMERUS. FOLLOWING SURGERY, THE PT DEVELOPED SEPTIC SHOCK & IS NOW DECEASED. THE CAUSE OF DEATH WAS MULTIPLE SYSTEM FAILURES SECONDARY TO SEPTIC SHOCK. THE DR REPORTED THAT HE DID NOT KNOW THE SOURCE OF THE INFECTION. THE PT HAD A TOTAL OF THREE SURGERIES. THE INITIAL SURGERY WAS APPROX 19 MONTHS PRIOR TO THE THIRD. THE FIRST INJURY OCCURRED WHEN THE PT WAS RECOVERING FROM A PYELONEPHRITIS AT HOME AND FAINTED, FRACTURING HER HUMERUS. A RUSH PIN WAS PLACED. NO GRAFT MATERIAL WAS USED AT THAT TIME. THE PIN MIGRATED PROXIMALLY AND WAS REMOVED 3 MONTHS POST-PLACEMENT. DURING THE SECOND PROCEDURE, THE DR PLACED A TRUFLEX NAIL AND A MODIFIED TENSION BANK. AGAIN, NO GRAFT MATERIAL WAS USED TO REPAIR THE FRACTURE. THE TRUFLEX NAIL ALSO MIGRATED PROXIMALLY AND WAS IMPINGING THE PT'S SHOULDER. THEREFORE, THE DR OPERATED A THIRD TIME. ON TUESDAY, APRIL 29, IN AN OUTPATIENT PROCEDURE, THE DR REMOVED THE TRUFLEX NAIL AND ELECTED TO PLACE PRO OSTEON. THE DR STATED THAT IT WAS APPARENT DURING THE PROCEDURE THAT THE PT WAS UNSTABLE AT THE FRACTURE SITE. THE FOLLOWING FRIDAY, MAY 2, THE PT COMPLAINED OF PERSISTENT NAUSEA, FEVER, AND PERIPHERAL SWELLING. DR REFERRED THE PT TO HER INTERNIST WHO ADMITTED HER TO THE HOSPITAL. THE PT PRESENTED IN SEPTIC SHOCK AND WAS ADMITTED TO ICU AND PLACED ON A VENTILATOR. DR SAW THE PT ON MAY 5, AT WHICH TIME THE SKIN STAPLES, HARDWARE AND APPROXIMATELY 90% OF THE GRAFT MATERIAL WERE REMOVED. THE DR CONTINUED TO IRRIGATE THE WOUND DAILY AND REMOVE THE REMAINING GRANULES OF PRO OSTEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FL Implant ENDOSSEOUS IMPLANT LMN INTERPORE INTL. NA 512709

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death