BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS EXTENSION PIECE 80MM

    MDR report key: 4197815 · Received October 23, 2014

    Report

    Report Number
    0002249697-2014-03967
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING TAPER-LOCK DISASSOCIATION INVOLVING A GMR EXTENSION PIECE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: THE SURFACE OF THE INTERNAL TAPER SHOWS LIGHT DAMAGE/MARKINGS IN A CIRCUMFERENTIAL PATTERN AND IS CONSISTENT WITH IT HAVING BEEN LOCKED AGAINST AN EXTERNAL TAPER AND IS AS INTENDED, HOWEVER IT CANNOT BE DETERMINED IF THERE WAS A COMPLETE AND SECURE TAPER LOCK. THE REMAINING DAMAGE OBSERVED ON THE SUBJECT DEVICE IS CONSISTENT WITH CLINICAL USE AND POST-FAILURE AND EXPLANTATION DAMAGE. TE SUBJECT DEVICE IS DIMENSIONALLY WITHIN SPECIFICATION. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR A COMPREHENSIVE REVIEW BUT FOLLOWING WERE THE CLINICIAN'S COMMENTS: SEVERAL DISASSOCIATION MECHANISMS COME INTO POTENTIAL CONSIDERATION: -SOFT TISSUE INTERPOSITION IN THE TAPER JUNCTION MAY HAVE PREVENTED FULL AND HARD LOCKING OF THE DEVICE. -DURING REVISION SURGERY, A 20-MM LONGER EXTENSION PIECE WAS IMPLANTED. THIS MAY INDICATE THAT THE PREVIOUS EXTENSION PIECE WAS LAX AND DID INCOMPLETELY RESTORE STABILITY AND/OR LEG LENGTH. THIS MEANS THAT AXIAL STABILITY OF THE KNEE HAD BECOME COMPROMISED AND THAT DURING THE SWING PHASE OF THE GAIT CYCLE THERE WAS LITTLE TO NO PROTECTION AGAINST DISTRACTION FORCES ACROSS THE KNEE JOINT. ASSUMING SUCH AN UNSTABLE CONDITION, IT MAY WELL BE THAT THE SIGNIFICANT WEIGHT OF THE COMBINED GMR'S DEVICES AND THE ATTACHED LOWER LEG NOT BALANCED BY ADEQUATE SOFT TISSUES ACROSS THE KNEE CAUSED AN OVERLOAD CONDITION OF DISTRACTION FORCES DURING THE SWING PHASE OF THE GAIT CYCLE CAUSING DISASSOCIATION OF THE TAPER CONNECTION. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED FOR REVIEW. FURTHER INFORMATION SUCH AS RETURN OF THE STEM, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. IT IS NOTED THAT THE STEM WAS NOT RETURNED AS IT REMAINS IMPLANTED AND THEREFORE ITS TAPER GEOMETRY CANNOT BE VERIFIED. INSPECTION OF THE RETURNED EXTENSION PIECE INDICATES CLINICAL USE AS INTENDED WITH SOME POST-FAILURE AND EXPLANTATION DAMAGE AND CONFIRMS THAT THE DEVICE IS DIMENSIONALLY WITHIN SPECIFICATION. THE CLINICAL CONSULTANT COMMENTED THAT POSSIBLE SCENARIOS MAY HAVE BEEN: SOFT TISSUE INTERPOSITION IN THE TAPER JUNCTION PREVENTING FULL AND HARD LOCKING OF THE CONNECTING TAPERS, OR COMPROMISED AXIAL STABILITY OF THE KNEE AS A TOO SHORT EXTENSION PIECE HAD BEEN ORIGINALLY IMPLANTED, LEADING TO AN OVERLOAD CONDITION OF DISTRACTION FORCES DURING THE SWING PHASE OF THE GAIT CYCLE CAUSING DISASSOCIATION OF THE TAPER CONNECTION.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SURGEON FROM (B)(6) HOSPITAL REPORTED TO STRYKER SALES REP. THAT AFTER PRIMARY SURGERY PERFORMED ON (B)(6) , THE EXTENSION PIECE IS OUT OF THE STEM. A REVISION SURGERY ON (B)(6) HAS BEEN PERFORMED AND THE EXTENSION PIECE HAS BEEN CHANGED. HAS BEEN USED A LONGER ONE 100MM 6495-6-100, LOT: EB78M.

    Description of Event or Problem · 1

    THE SURGEON FROM (B)(6) HOSPITAL REPORTED TO STRYKER SALES REP. THAT AFTER PRIMARY SURGERY PERFORMED ON (B)(6), THE EXTENSION PIECE IS OUT OF THE STEM. A REVISION SURGERY ON (B)(6) HAS BEEN PERFORMED AND THE EXTENSION PIECE HAS BEEN CHANGED. HAS BEEN USED A LONGER ONE 100MM 6495-6-100 LOT: EB78M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676257 GMRS EXTENSION PIECE 80MM IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH LBFMY

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R