BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOCLASSIC, SL STEM, UNCEMENTED, 5, TAPER 12/14

    MDR report key: 6860878 · Received September 13, 2017

    Report

    Report Number
    0009613350-2017-01214
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Report Date
    January 11, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK030373
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMETS REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFORE TRIED SEVERAL TIMES TO RECEIVE ADDITIONAL INFORMATION FOR THIS CASE. THE MISSING INFORMATION WAS REQUESTED AT COMPLAINANT THE LATEST ONE ON (B)(6) 2017 BUT WAS NOT AVAILABLE. DEVICE HISTORY RECORDS: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: DURING SURGERY, IT WAS FOUND THAT HEAD NECK DID NOT FIT PROPERLY TO ALLOCLASSIC STEM NECK. SURGERY WAS DELAYED DUE TO FITTING ISSUE. THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) WITH REFERENCE NUMBER (B)(4) (HEAD). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. THE MISSING INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED, THE PRODUCT LOCATION IS UNKNOWN (PRESUMEDLY IMPLANTED). REVIEW OF PRODUCT DOCUMENTATION THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: INTRAOPERATIVE COMPLICATIONS DUE TO INCORRECT ASSOCIATED INSTRUMENTS USED POSSIBLE, NO DETAIL ABOUT THE IMPLANTATION SURGERY ARE AVAILABLE. THEREFORE THIS CANNOT BE EXCLUDED. INTRAOPERATIVE COMPLICATIONS DUE TO DESIGN SPECIFICATION NOT MET. NOT POSSIBLE. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. INTRAOPERATIVE COMPLICATIONS DUE TO MISSING COMPONENT IN SET PACKAGE. NOT POSSIBLE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. INTRAOPERATIVE COMPLICATIONS DUE TO INADEQUATE HANDLING DURING TRANSPORT/STORAGE POSSIBLE, THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. HOWEVER, INADEQUATE HANDLING CANNOT BE EXCLUDED. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE ATTACHMENT FORCE POSSIBLE, NO DETAIL ABOUT THE IMPLANTATION SURGERY ARE AVAILABLE. THEREFORE THIS CANNOT BE EXCLUDED. INTRAOPERATIVE COMPLICATIONS DUE TO WRONG HANDLING OF INSTRUMENTATION POSSIBLE, NO DETAIL ABOUT THE IMPLANTATION SURGERY ARE AVAILABLE. THEREFORE THIS CANNOT BE EXCLUDED. INTRAOPERATIVE COMPLICATIONS DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT. NOT POSSIBLE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. INTRAOPERATIVE COMPLICATIONS DUE TO INSUFFICIENT DESCRIPTION OF SURGICAL PROCESS LEADS TO INTRAOPERATIVE ERRORS OR MISUSE OF IMPLANT OUTSIDE OF ITS SCOPE. NOT POSSIBLE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. CONCLUSION SUMMARY: IT WAS REPORTED THAT DURING :SURGERY, IT WAS FOUND THAT HEAD NECK DID NOT FIT PROPERLY TO ALLOCLASSIC STEM NECK. SURGERY WAS DELAYED DUE TO FITTING ISSUE. NO OTHER DETAIL IS AVAILABLE. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A ALLOCLASSIC, SL STEM, UNCEMENTED, 5, TAPER 12/14 ON AN UNKNOWN SIDE ON AN UNKNOWN DATE AND THAT HEAD NECK DID NOT FIT PROPERLY TO ALLOCLASSIC STEM NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641585 ALLOCLASSIC, SL STEM, UNCEMENTED, 5, TAPER 12/14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM LZO ZIMMER GMBH N/A 2879479

    Patients

    Seq Age Sex Outcome Treatment
    1