BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 5 ACCOLADE II 127 DEG

    MDR report key: 6419717 · Received March 20, 2017

    Report

    Report Number
    0002249697-2017-00964
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 21, 2017
    Report Date
    May 12, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540669506
    PMA / PMN Number
    K143085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FOREIGN MATERIAL INVOLVING A ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS CARRIED OUT ON THE RETURNED PART (REFERENCE PHOTOGRAPHS OF RETURNED PART DOC. ATTACHED ) THE PRESENCE OF A EPOXY LIKE SUBSTANCE WAS NOTED ON THE TAPER OF THE STEM. . MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: AN NC WAS RAISED TO INVESTIGATE THE EVENT. THE NC CONCLUDED: AS THE ANALYSIS OF THE RESIDUE WAS SILICON BASED,A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED, IT WAS DETERMINED THAT THE MASKING TAPES (4 DIFFERENT TYPES) USED IN THE COATINGS CELL ARE DIRECTLY IN CONTACT WITH THE PRODUCT. IT WAS DECIDED TO SEND THESE TAPES TO THE STRYKER MATERIAL SCIENTIST IN STRYKER (B)(4) FOR ANALYSIS. RESULTS FROM SECOND TECHNICAL REPORT CONFIRMED THAT ALL MASKING TAPES WERE SILICON BASED ADHESIVES AND ALL WERE POTENTIAL CANDIDATES FOR RESIDUE TRANSFER, BUT IT COULD NOT BE CONCLUDED THAT THESE TAPES WERE A 100% MATCH TO THE RESIDUE IN THE CUSTOMER COMPLAINT. PRIMARY ROOT CAUSE OF ESCAPE IS LIKELY TO BE THE RESIDUE WHICH WAS MISSED DURING ROUTINE VISUAL INSPECTION DURING SUBSEQUENT DOWN STREAM PROCESS STEPS.

    Description of Event or Problem · 1

    ACCOLADE II SHAFT GOT SCRATCHES AT THE CONE AND ON THE COATING WERE PIECES OF FLUFF DETECTED. UPDATE (B)(6) 2017 FOLLOWING CON CALL WITH SALES REP. SALES REP. CONFIRMED THAT HE WAS NOT IN ATTENDANCE ON THE DAY, SURGEON CALLED HIM ON THE DAY OF THE SURGERY, SURGEON STATED THAT HE NOTICED FLUFF ON THE COATING OF THE STEM AND REMOVED IT BUT HE THEN INSPECTED THE REST OF THE STEM AND NOTICED "DIRT" ON THE NECK OF THE STEM AND AS A RESULT DECIDED NOT TO IMPLANT.

    Description of Event or Problem · 1

    ACCOLADE II SHAFT GOT SCRATCHES AT THE CONE AND ON THE COATING WERE PIECES OF FLUFF DETECTED. UPDATE 07 MARCH 2017 FOLLOWING CON CALL WITH SALES REP. SALES REP. CONFIRMED THAT HE WAS NOT IN ATTENDANCE ON THE DAY, SURGEON CALLED HIM ON THE DAY OF THE SURGERY, SURGEON STATED THAT HE NOTICED FLUFF ON THE COATING OF THE STEM AND REMOVED IT BUT HE THEN INSPECTED THE REST OF THE STEM AND NOTICED "DIRT" ON THE NECK OF THE STEM AND AS A RESULT DECIDED NOT TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199293 SIZE 5 ACCOLADE II 127 DEG STHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 56599604 04546540669506

    Patients

    Seq Age Sex Outcome Treatment
    1 Other