BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 6571617 · Received May 17, 2017

    Report

    Report Number
    0009613350-2017-00654
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    March 29, 2017
    Report Date
    May 17, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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).

    Additional Manufacturer Narrative · 1

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE. NEITHER THE HEALTHCARE FACILITY NOR THE DOCTOR WERE ABLE TO PROVIDE ADDITIONAL INFORMATION. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO PERFORM, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. DHR REVIEW: AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. AT ZIMMER GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. TREND ANALYSIS: THE TREND ANALYSIS COULD NOT BE PERFORMED AS NO ITEM NUMBER WAS AVAILABLE. REVIEW OF EVENT DESCRIPTION: IN THE RECEIVED BFARM USER REPORT IT WAS REPORTED THAT A LONG NCB PLATE WAS BROKEN. THE PLATE (APPROX. 30 CM LENGHT) WAS FIXED WITH A CABLE READY. NO FURTHER INFORMATION WAS RECEIVED. THE NUMBERS 20161121000021/20161121000005 WERE GIVEN AS SERIEN / CHARGEN (S/N) NUMBERS IN THE USER REPORT, BUT IT DOES NOT CORRESPOND TO A CATALOGUE NUMBER OR A LOT NUMBER OF A PRODUCT (IT SEEMS TO BE A DATE). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: - BREAKAGE OF IMPLANT DUE TO MOVEMENT BETWEEN IMPLANTS LEADS TO NOTCHING / FRETTING => POSSIBLE, AS THE IMPLANT WAS NOT RETURNED FOR INVESTIGATION AND A CABLE READY WAS USED DURING THE IMPLANTATION IT IS POSSIBLE THAT NOTCHING OCCURRED. - BREAKAGE OF IMPLANT DUE TO INADEQUATE IMPLANT DESIGN & MATERIAL (FATIGUE STRENGTH - LIFETIME OF THE DEVICE) => NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT OR IN THE CURRENT PMS PROCESS. - BREAKAGE OF IMPLANT DUE TO CHEMICAL / GALVANIC / CREVICE CORROSION OF MATERIAL => POSSIBLE, AS THE IMPLANT WAS NOT RETURNED FOR INVESTIGATION IT CANNOT BE SEEN IF CORROSION OCCURRED. - BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF IN SITU DEVICE POSITION AND/OR DIMENSION => POSSIBLE, NO X-RAYS RECEIVED, THEREFORE THIS POINT IS POSSIBLE. - BREAKAGE OF IMPLANT DUE TO WRONG INTERPRETATION OF X-RAY TEMPLATE FOR DIMENSIONS => POSSIBLE, NO X-RAYS RECEIVED, THEREFORE THIS POINT IS POSSIBLE. - BREAKAGE OF IMPLANT DUE TO USER PERFORM INADEQUATE FORCE TO THE PLATE => POSSIBLE, NO SURGICAL REPORTS RECEIVED. IT IS UNKNOWN HOW THE USER DID INSERT THE PLATE. - BREAKAGE OF IMPLANT DUE TO USER DEFINE INCORRECT PLACEMENT OF THE SPACERS AND PLATE => POSSIBLE, THE POSITION CANNOT BE SEEN AS NO X-RAYS WERE RECEIVED. - BREAKAGE OF THE IMPLANT DUE TO USER PERFORMES INADEQUETE FORCES TO THE PLATE => POSSIBLE, NO SURGICAL REPORTS RECEIVED. IT IS UNKNOWN HOW THE USER DID INSERT THE PLATE. - BREAKAGE OF THE IMPLANT DUE TO USER PERFORM IMPROPER HANDLING OF THE PLATE DURING INSERTION => POSSIBLE, NO SURGICAL REPORTS RECEIVED. IT IS UNKNOWN HOW THE USER DID INSERT THE PLATE. - BREAKAGE OF THE IMPLANT DUE TO WRONG/ INCOMPLETE INFORMATION ABOUT LIMITATION AND POSTOPERATIVE RESTRICTION => POSSIBLE, NO POST OP INFORMATION WAS RECEIVED. - BREAKAGE OF THE IMPLANT DUE TO PATIENT DO NOT FOLLOW THE POSTOPERATIVE PROTOCOL => POSSIBLE, NO SPECIFIC PATIENT INFORMATIUON WAS RECEIVED. CONCLUSION SUMMARY IT WAS REPORTED THAT A LONG NCB PLATE WAS BROKEN. IT IS UNKNOWN HOW LONG THE PLATE WAS IMPLANTED UNTIL THE BREAKAGE OCCURRED. IT CAN BE POSSIBLE THAT THE PLATE WAS OVERSTRESSED DURING THE IN VIVO TIME OR A WRONG PATIENT BEHAVIOR LEAD TO THE BREAKAGE OF THE PLATE. AS NO X-RAYS OR SURGICAL REPORTS WERE RECEIVED IT CAN NO BE SEEN HOW AND IN WHICH POSITION THE PLATE WAS FIXED ON THE BONE AND FOR WHICH INDICATION IT WAS INSERTED. THERE ARE ALSO NO SPECIFIC PATIENT INFORMATION AVAILABLE SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. THE CONDITION OF THE BROKEN PLATE (FRACTURE AREAS) CANNOT BE EVALUATED AS THE DEVICE WAS NOT SENT BACK FOR INVESTIGATION. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO DETERMINE AN EXACT ROOT CAUSE OF THE REPORTED EVENT. 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 AN UNKNOWN NCB PLATE ON AN UNKNOWN DATE. THE PLATE BROKE ON (B)(6) 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353790 UNKNOWN NCB PLATE NCB PLATING SYSTEM HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR