BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METASUL HEAD 28MM L 12/14

    MDR report key: 7746422 · Received August 3, 2018

    Report

    Report Number
    0009613350-2018-00755
    Event Type
    Injury
    Date Received
    August 3, 2018
    Report Date
    August 3, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS ACCORDING: ALLOFIT ALLOCLASSIC SHL 54/JJ, ITEM#:01.00010.410, LOT#: 2427264; METASUL, ALPHA INSERT, JJ/28, ITEM#: 192807, LOT#: 2447393; ALLOCLASSIC SL STEM 5 12/14, ITEM#: 2845, LOT#: 2460103. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00722, 0009613350 - 2018 - 00753, 0009613350 - 2018 - 00755, 0009613350 - 2018 - 00756. THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E REF# (B)(4), METASUL KOPF 32, 12/14, GRÖSSE M/0, K091973) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICES OR ADDITIONAL INFORMATION ARE BEING SUBMITTED FOR REVIEW. ZIMMER (B)(4) (B)(6) LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER (B)(4) NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER (B)(4) AS MUCH INFORMATION AS THEY ARE WILLING TO SHARE TO PROTECT THE RIGHTS OF THEIR CLIENTS. ALL INFORMATION WHICH HAS BEEN PROVIDED FOR THIS PARTICULAR CASE IS ALREADY COVERED IN THE FINAL REPORT. NEVERTHELESS, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO US, A FOLLOW UP REPORT WILL BE SUBMITTED. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND ANALYSIS COULD BE PERFORMED AS NO SPECIFIC EVENT INFORMATION IS AVAILABLE. REVIEW OF EVENT DESCRIPTION: A LEGAL WRIT WAS RECEIVED INDICATING THAT A PATIENT MIGHT HAVE PROBLEMS WITH A ZIMMER BIOMET THA. THE LEGAL DOCUMENT DOES NEITHER CONTAIN ANY INFORMATION ABOUT THE HAZARDOUS SITUATION NOR THE HARM. EXCEPT OF FOUR ZIMMER BIOMET DEVICES (REFERENCE AND LOT NUMBERS), NO MEDICAL DATA WERE PROVIDED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL SELECTION OF POSSIBLE RISKS FOR THE PATIENT. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE CORRESPONDING RISK MANAGEMENT FILES FOR ALLOFIT ALLOCLASSIC SHELL 54/JJ, METASUL ALPHA INSERT JJ/28, METASUL HEAD AND ALLOCLASSIC SL STEM 12/14. CONCLUSION SUMMARY: NEITHER AN EVENT DESCRIPTION (HAZARDOUS SITUATION OR HARM), MEDICAL DATA, NOR DEVICE DETAILS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, 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 BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). NOTE:SAME PATIENT UNDERWENT BILATERAL SURGERY IMPLANT ON THE RIGHT SIDE, CASE: (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY ON THE LEFT SIDE AND IS BEING MONITORED DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587812 METASUL HEAD 28MM L 12/14 KWA ZIMMER GMBH N/A 2447393

    Patients

    Seq Age Sex Outcome Treatment
    1 Other