BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS. HIP ENDOPROSTHESIS

    MDR report key: 7373782 · Received March 27, 2018

    Report

    Report Number
    0002249697-2018-00884
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    March 5, 2018
    Report Date
    June 6, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING PRODUCT MIX INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION:. VISUAL INSPECTION OF THE LABEL ON THE RETURNED DEVICE PACKAGING INDICATED THE DEVICE TO HAVE A 52MM DIAMETER. VISUAL INSPECTION OF THE ETCHING ON THE RETURNED DEVICE INDICATED THE DEVICE TO HAVE A 56MM DIAMETER. DIMENSIONAL INSPECTION: THIS DEVICE IS MANUFACTURED BY LISI. LISI COMPLETED A DIMENSIONAL INSPECTION AS PER NC WHICH CONCLUDED 'THE COMPLAINT PART REF: 0590-3-056 / LOT: G7248075 WAS RECEIVED IN LMO ON MARCH 09TH 2018. A DIMENSIONAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THE SIZE IS 56.' FUNCTIONAL INSPECTION: NOT PERFORMED AS THE FUNCTIONAL ASPECTS ARE NOT IN QUESTION. MATERIAL ANALYSIS: NOT PERFORMED AS THIS EVENT DOES NOT RELATE TO MATERIAL INTEGRITY. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. 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 HAS BEEN RAISED TO INVESTIGATE THE EVENT: THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE RELATED TO NON-RESPECT OF LINE CLEARANCE REQUIREMENTS AT THE PRINTING LABELLING OPERATION. BATCHES WERE PROCESSED AT THE SAME TIME AT THE LABEL PRINTING OPERATION. THE SUPPLIER CONFIRMED THROUGH A TRIAL THAT THE OPERATOR COULD NOT HAVE COMPLETED THE REQUIREMENTS OF THE LABELLING OPERATION FOR THE LOT ID'S REPORTED THROUGH THE COMPLAINT BASED ON TIMINGS FROM AUDIT TRAIL, THEREFORE THE OPERATOR DID NOT COMPLY WITH LINE CLEARANCE REQUIREMENTS. IT WAS CONCLUDED BY THE SUPPLIER THAT WHEN THE OPERATOR WAS RECONCILING THE DHR'S WITH THE PARTS, THE MIX UP OCCURRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CUSTOMER OPENED A 52MM ETS HIP ENDOPROSTHESIS ON THE BOX AND 52MM ON THE INNER WRAPPER. ON WAITING FOR THE CEMENT TO SET, THE SURGEON NOTED THAT THE SIZE WRITTEN ON THE PROSTHESIS WAS 56. THE PROSTHESIS WAS IMMEDIATELY REMOVED AND AS MUCH CEMENT WAS AS POSSIBLE. THE SURGEON TOOK REMEDIAL ACTION TO ENSURE THAT ANOTHER PROSTHESIS CAN BE IMPLANTED. THE SURGERY WAS EXTENDED BY 90 MINUTES. THE PATIENT HAD TO HAVE CEMENT IMPLANTED TWICE. DUE TO THE FACT THAT THE SURGEON COULDN¿T REMOVE ALL OF THE CEMENT MANTLE, DIFFERENT IMPLANTS WERE USED INSTEAD.

    Additional Manufacturer Narrative · 1

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CUSTOMER OPENED A 52MM ETS HIP ENDOPROSTHESIS ON THE BOX AND 52MM ON THE INNER WRAPPER. ON WAITING FOR THE CEMENT TO SET, THE SURGEON NOTED THAT THE SIZE WRITTEN ON THE PROSTHESIS WAS 56. THE PROSTHESIS WAS IMMEDIATELY REMOVED AND AS MUCH CEMENT WAS AS POSSIBLE. THE SURGEON TOOK REMEDIAL ACTION TO ENSURE THAT ANOTHER PROSTHESIS CAN BE IMPLANTED. THE SURGERY WAS EXTENDED BY 90 MINUTES. THE PATIENT HAD TO HAVE CEMENT IMPLANTED TWICE. DUE TO THE FACT THAT THE SURGEON COULDN'T REMOVE ALL OF THE CEMENT MANTLE, DIFFERENT IMPLANTS WERE USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215561 ETS. HIP ENDOPROSTHESIS HIP IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G7248077

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R