BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCB PP PROX FEM PLATE, L, 18 H, L. 363 MM

    MDR report key: 4901388 · Received July 7, 2015

    Report

    Report Number
    9613350-2015-00720
    Event Type
    Other
    Date Received
    July 7, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND WAS IDENTIFIED. IT IS REPORTED THAT THE OUTER PACKAGE, THE PLATE AND THE LABELS ARE LABELED WITH THE REF. (B)(4), LOT: 2806094, WHICH CORRESPOND TO THE PRODUCT. THE INNER PACKAGE IS LABELED WITH A DIFFERENT REFERENCE, REF.: (B)(4), LOT: 2804066. THE EVENT WAS DISCOVERED AT THE HOSPITAL WHILE PACKING THE GRAPHIC CASE FOR THE CUSTOMER. DEVICES ANALYSIS (VISUAL EXAMINATION): THE PLATE (NCB PP PROX. FEMUR PLATE, L, 18L, 363MM), AND THE LABELS ARE LABELED WITH THE REF. (B)(4), LOT: 2806094, WHICH CORRESPOND TO THE PRODUCT. THE INNER PACKAGE IS LABELED WITH THE REF. (B)(4) (NCB PP DIST. FEMUR PLATE, L, 18L, 355MM), LOT: 2804066. THE PRODUCT AND THE PACKAGING DO NOT SHOW ANY UNCONFORMITIES. NO OTHER TESTS WERE RELEVANT FOR THE INVESTIGATION. REVIEW OF INTERNAL DOCUMENTS: THE ANALYSIS OF THE DEVICE HISTORY RECORDS OF BOTH LOTS SHOWED THE FOLLOWING: LOT 2804066 WAS PACKAGED AND FINISHED BETWEEN JUNE 13,.2015 AND JUNE 15, 2015; LOT 2806094 WAS PACKAGED AND FINISHED BETWEEN JUNE 20,.2015 AND JUNE 22, 2015; THE "LOG AUSDRUCK FINAL" SHEETS OF THE LABELS FOR BOTH LOTS SHOW THAT NO MORE LABELS THAT THE ONE NEEDED FOR THE PRODUCT DURING MANUFACTURING WERE PRINTED; NO REWORK OR NCR WAS PERFORMED FOR BOTH LOTS. "KANTONSSPITAL WINTERTHUR" WERE ORIGINALLY DELIVERED WITH PARTS FROM EACH LOTS; PROCESS "PACKAGING OF UNSTERILE PRODUCTS" SPECIFY TO SCAN EACH BARCODE LABEL TO CHECK THEM. POSSIBLE ROUTE CAUSES: POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO SAP DFMEA: MIX-UP WHICH COULD LEAD TO THE IMPLANTATION OF A DAMAGED IMPLANT -> DUE TO NO INSTRUCTIONS GIVEN ON STORAGE AND HANDLING; POSSIBLE AS POSSIBLE MISHANDLING COULD HAVE LED TO THE MIX UP OF THE PRODUCT PACKAGE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. MISHANDLING COULD HAVE LED TO THE MIX UP OF THE PRODUCT PACKAGE. BASED ON THE INITIAL RESULTS, IT CAN BE EXCLUDED THAT THE MIX-UP OCCURRED INTERNALLY, WITHIN ZIMMER LOGISTICAL CONTROL. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE THE LOT NUMBER WAS RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LABELING MISTAKE WAS DETECTED WHILE PACKING THE GRAPHIC CASE FOR THE CUSTOMER: THE OUTER PACKAGE WAS LABELED WITH THE CORRECT REFERENCE NUMBER 02.03263.118, THE INNER PACKAGE WAS LABELED WITH THE WRONG REFERENCE NUMBER 02.03264.118. THE IMPLANT ITSELF WAS CORRECTLY LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440855 NCB PP PROX FEM PLATE, L, 18 H, L. 363 MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOC HRS ZIMMER GMBH NA 2806094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other