BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, JJ/36

    MDR report key: 6442352 · Received March 29, 2017

    Report

    Report Number
    0009613350-2017-00462
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    February 4, 2017
    Report Date
    March 29, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4). THE ACTUAL SIZE OF THE DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH OTHER SIZES (I.E DURAL ALPHA INSERT NEUTR GG/32) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.¿

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: NO TREND IDENTIFIED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. VENT DESCRIPTION (EVENT DETAILS, PER) EVENT SUMMARY: IT WAS REPORTED THAT DURING THE SURGERY DURASUL ALPHA INSERT, JJ/36 (REF: 01.00013.710 LOT: 2870166) COULD NOT BE LOCKED INTO THE ALLOFIT ALLOCLASSIC SHELL 54/JJ (REF: 4246 LOT: 2875546). THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER DURASUL ALPHA INSERT IN A DIFFERENT SIZE (REF: 01.00013.410 LOT: 2872732). NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS - VISUAL EXAMINATION: DURASUL ALPHA INSERT JJ/36 (REF: 01.00013.710) WAS RECEIVED FOR THE INVESTIGATION. THE FRONT SURFACE OF THE INSERT INCLUDING THE SNAP FIT AREA SHOW CLEAR CUTS AND MARKS FROM THE SETTING INSTRUMENT. ON THE ARTICULATING SLIGHT SCRATCHES ARE DETECTED. THE BOTTOM SURFACE OF THE INSERT DOES NOT PRESENT ANY METALLIC SHELL-SPIKE SOURCED INDENTS, WHICH WOULD IMPLY THAT A SECURE CONNECTION BETWEEN THE SHELL AND THE INSERT IS ESTABLISHED. SIGNIFICANT CUTS AND SCRATCHES ARE PRESENT AT THE RIM AND ON THE BOTTOM SURFACE. SOME SCRATCHES IMPLY THAT THE LINER WAS NOT IMPACTED CORRECTLY AND THE ROTATION OF THE LINER IN THE SHELL LED TO THESE SCRATCHES DUE TO THE SPIKES. THE PEG AT THE BOTTOM SURFACE OF INSERT FOR CENTERING THE INSERT IS DEFORMED AND HAS SCRATCHES AT THE TIP. - TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED WITH THE CALIPER Z 7568 (MEASUREMENT ACCURACY +0.1/- 0.1 MM) AND COMPARED WITH THE RESPECTIVE DRAWING .CHARACTERISTIC "DIAMETER" -SPECIFICATION: 48.69 +0.05/-0.05 MM-MEASURED VALUE: 48.71 MM (WITHIN SPECIFICATION) - NO FUNCTIONAL TEST IS PERFORMED AS THE PEG IS DEFORMED TO ALLOW A CORRECT POSITION WITHIN THE PLUG. 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. - INSPECTION PLAN (DURASUL ALPHA INSERT): - CHARACTERISTIC "DIAMETER" BY 100% QUALITATIVE INSPECTION WITH GAGE, QUANTITATIVE INSPECTION AQL 0.65, AUTOMATED INSPECTION AQL 1.0. MEANS OF INSPECTION: 3D-MESSMASCHINE. - THE SURGICAL TECHNIQUE FOR ALLOFIT/ALLOFIT-S ALLOCLASSIC ACETABULAR SYSTEM STATES THAT CLEAN AND DRY THE INNER SURFACE OF THE SHELL, CONNECT THE LINER TO THE SETTING INSTRUMENT, POSITION THE LINER OVER THE ENTRANCE PLANE OF THE SHELL AND ROTATE CLOCKWISE. THE PEG OF THE POLYETHYLENE LINER MUST BE INSERTED INTO THE POLE PLUG HOLE. COMPLETE SEATING OF THE LINER WITH A LIGHT HAMMER BLOW. IF THE LINER CAN STILL BE ROTATED AFTER LIGHT IMPACTION, THIS INDICATES MISPOSITIONING, NONCONCENTRIC, OR SOFT TISSUES INTERFERENCE BETWEEN THE LINER AND THE SHELL SURFACES. IN SUCH SITUATION, REMOVE THE LINER, CLEAN BOTH SURFACES AND INTRODUCE THE LINER BACK INTO THE SHELL, MAKING SURE IT IS PROPERLY CENTERED AND REPEAT THE SEATING PROCEDURE. ONCE THE LINER REMAINS STEADY AFTER LIGHT HAMMER BLOWS, FINALIZE SEATING WITH FINAL IMPACTION. WHERE NECESSARY, A TAP PLASTIC IMPACTOR PROVIDES CONFIRMATION THAT THE CONNECTION IS RELIABLE. IF THE INSERT HAS SNAPPED INTO PLACE CORRECTLY, THE EDGE IS PROTRUDING AROUND 1.5 MM OVER THE EQUATOR OF THE TITANIUM SHELL.NOTE: IF UNSURE, THE SEATING CAN BE CHECKED USING A RASPATORY. IF THE FITTING OF THE INSERT IS FAULTY, A NEW INSERT MUST BE USED. IF THE POLAR PEG IS DEFORMED, IT WILL NOT BE POSSIBLE TO ANCHOR THE INSERT CORRECTLY. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: - DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE POLAR PLUG: POSSIBLE: THE POLAR PLUG IS DAMAGED.- DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE POLAR THREAD OF THE SHELL: POSSIBLE: THE SHELL WAS NOT RECEIVED FOR THE INVESTIGATION, THEREFORE THIS RISK CANNOT BE EXCLUDED. - DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO FRACTURE OF THE PELVIS: NOT POSSIBLE: AS NO PELVIS FRACTURE IS REPORTED. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG PAIRING OF COMPONENTS (WRONG SIZE): NOT POSSIBLE: THE PAIREDCOMPONENTS HAVE CORRECT SIZES ACCORDING TO THE IMPLANT STICKERS RECEIVED. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT (WRONG PAIRING) DUE TO WRONG SELECTION OF PARTS DUE TO UNKNOWN COMPATIBILITY: NOT POSSIBLE: THE PAIRED PARTS ARE COMPATIBLE WITH EACH OTHER. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG ASSEMBLY PROCEDURE: POSSIBLE: DAMAGES (DEFORMED PEG ON THE INSERT, SCRATCHES DUE TO THE PINS OF THE SHELL) INDICATE THE INSERT WAS NOT CENTERED CORRECTLY WITHIN THE SHELL PRIOR TO IMPACTION WITH THE HAMMER. CONCLUSION SUMMARY: REVIEW OF THE DHR OF RETURNED INSERT WITH SIZE JJ/36 INDICATES THAT THE DEVICES MET ALL REQUIREMENTS TO PERFORM AS INTENDED. MOREOVER, THE CORRECT SIZE CAN BE CONFIRMED. NO PROBLEMS RELATED TO INSERT WERE OBSERVED. THE VISUAL EXAMINATION OF THE DURASUL ALPHA INSERT SHOWED THAT THERE WERE NO PAIRED, SYMMETRICAL INDENTS. IN CASE THE INSERT IS CORRECTLY SEATED IN THE METALLIC SHELL, TWO SYMMETRICALLY ALIGNED INDENTS SHOULD BE VISIBLE DUE TO THE CONTACT WITH THE SPIKES OF THE SHELL. THE DETECTED DAMAGES/IMPERFECTIONS (DEFORMED PEG ON THE INLAY AND SCRATCHES CAUSED BY THE PINS OF THE SHELL) INDICATE AN EXPERIENCED DIFFICULTY WITH CENTERING THE INSERT WITHIN THE SHELL PRIOR TO IMPACTION. IF THE INSERT GETS IMPACTED WITHOUT BEING CORRECTLY CENTERED, THE CENTERING PEG GETS DEFORMED AND EXPANDED MAKING IT SUBSEQUENTLY EVEN MORE DIFFICULT TO ACHIEVE A CORRECT POSITION AND AN ANCHORING OF THE INLAY. THE CORRECT WAY TO SEAT THE INLAY WITHIN THE SHELL IS EXPLAINED IN THE SURGICAL TECHNIQUE. FURTHER POSSIBLE CAUSES FOR THE REPORTED FAILURE INCLUDE THE SLIGHT DEFORMATION OF THE METALLIC SHELL DUE TO THE VERY HARD BONE CONDITIONS, SOFT TISSUE AND/ OR DEBRIS LEFT BETWEEN INSERT AND CUP PRIOR TO SEATING AND STORING THE INSERT IN A RATHER COLD PLACE WHICH MIGHT LEAD TO A SLIGHT DECREASE OF THE OUTER DIAMETER (MATERIAL REDUCTION). HOWEVER, IT IS NOT KNOWN TO WHICH EXTENT THESE FACTOR HAVE PLAYED A ROLE IN THE OBSERVED EVENT. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2017 A SURGEON COULD NOT LOCK A DURASUL ALPHA INSERT JJ/36 INTO THE CUP SIZE 54. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSERT IN A DIFFERENT SIZE WITH NO SURGERY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225539 DURASUL, ALPHA INSERT, JJ/36 UNKNOWN LZO ZIMMER GMBH N/A 2870166

    Patients

    Seq Age Sex Outcome Treatment
    1