BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL HEAD - 24MM

    MDR report key: 6253670 · Received January 16, 2017

    Report

    Report Number
    3004608878-2017-00012
    Event Type
    Injury
    Date Received
    January 16, 2017
    Date of Event
    December 7, 2016
    Report Date
    December 26, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    KWI
    PMA / PMN Number
    K032806
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON FEBRUARY 23, 2017. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: EVALUATION OF RETURNED DEVICE; THERE ARE FOUR PRIMARY FAILURE MODES THAT COULD RESULT IN DETACHMENT OF A KATALYST IMPLANT FOLLOWING IMPLANTATION; DEFECTS IN THE MANUFACTURING OF THE RADIAL HEAD / POLY ASSEMBLY OR THE RADIAL HEAD STEM ASSEMBLY; IMPROPER SURGICAL TECHNIQUE; DAMAGE TO THE IMPLANT DURING THE ASSEMBLY PROCESS; AND, POST-OPERATIVE DAMAGE TO THE IMPLANT DUE TO THE PATIENT¿S MEDICAL CONDITION OR BLUNT FORCE TRAUMA. DHR REVIEW; A REVIEW OF THE DEVICE HISTORY RECORDS DETERMINED THAT A QUANTITY OF (B)(4) OF THE 24 MM RADIAL HEAD/POLY ASSEMBLIES (P/N 22-1424, LOT # KV0035) WERE MANUFACTURED BY STD MEDICAL, LOCATED IN (B)(4), RECEIVED AT ILS (B)(4) ON NOVEMBER 2, 2012, INSPECTED AND PLACED INTO PBSI INVENTORY ON NOVEMBER 3, 2012. A REVIEW OF INSPECTION DATA FROM STD MEDICAL AND ILS (B)(4) QC DEPARTMENT DID NOT FIND ANY OUT-OF-SPECIFICATION (OOS) RESULTS COMPLAINTS HISTORY; A QUERY IN TRACKWISE FOUND TWO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE POST-OPERATIVE DETACHMENT OF THE RADIAL HEAD/POLY ASSEMBLY AND THE RADIAL HEAD STEM ASSEMBLY. INCLUDING THESE COMPLAINTS, THERE HAVE BEEN A TOTAL OF FOUR REPORTED COMPLAINTS REGARDING THE POST-OPERATIVE DETACHMENT OF THE RADIAL HEAD/POLY ASSEMBLY AND THE RADIAL HEAD STEM ASSEMBLY IN THE PAST 24 MONTHS. THE FOUR COMPLAINTS ARE ASSOCIATED WITH TWO SEPARATE SURGERIES, RESULTING IN A COMPLAINT RATE OF 0.501% BASED ON THE CALCULATED NUMBER OF 399 COMPLETED SURGERIES. CONCLUSION: THE PROBABLE ROOT CAUSE FOR THESE COMPLAINTS IS NONCOMPLIANCE FROM THE PATIENT TO FOLLOW POST-OPERATIVE CARE. IT ISN¿T CLEAR IF THE PATIENT¿S MEDICAL CONDITION ALSO CONTRIBUTED TO A FAILED PROSTHESIS.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    REPORT 2 OF 2: OTHER MFG REPORT NUMBER: 3004608878-2017-00011. IT WAS REPORTED THAT THE RADIAL HEAD COMPONENTS DISASSOCIATED WHILE THE PATIENT WAS SPLINTED WITHIN TWO WEEKS OF IMPLANTATION. ONCE REMOVED DURING A REVISION SURGERY, THE SURGEON REATTACHED THE HEAD AND THE STEM AND WAS ABLE TO PULL THE TWO PIECES APART WITH HER HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37619 RADIAL HEAD - 24MM KATALYST BIPOLAR RADIAL HEAD SYSTEM KWI INTEGRA LIFESCIENCES CORPORATION OH/USA KV0035

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention THE 221675 - STEM / SHAFT ASSY - 7.5MM