BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL ALPHA INSERT, GG/32

    MDR report key: 6367620 · Received March 1, 2017

    Report

    Report Number
    0009613350-2017-00286
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    February 9, 2017
    Report Date
    March 16, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW BUT IT WAS MENTIONED THAT IT WILL BE RETURNED. X-RAYS OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IDENTIFIED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT DURING THE SURGERY THE INLAY (REF: (B)(4), LOT: 2882169) COULD BE INSERTED, BUT IT HAD NO FIXATION AND REMAINED LOOSE IN THE ALREADY IMPLANTED ALLOFIT CUP (REF: 4243). THE SURGERY WAS EXTENDED FOR 10 MIN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER INLAY (REF: (B)(4) LOT: 2849706). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE DURASUL ALPHA INSERT GG/32 (REF: (B)(4)) WAS RECEIVED FOR THE INVESTIGATION. THE FRONT SURFACE OF THE INSERT INCLUDING THE SNAP FIT AREA SHOWS CLEAR CUTS AND MARKS FROM THE SETTING INSTRUMENT. ON THE ARTICULATING SURFACE NO DAMAGE IS DETECTED. THE ANCHORING SURFACE OF THE INSERT EXHIBITS MULTIPLE SHELL-SPIKE SOURCED INDENTS, WHICH WOULD IMPLY A SECURE CONNECTION BETWEEN THE SHELL AND THE INSERT HAS BEEN ESTABLISHED. THE NUMBER OF THE INDENTS IS NOT CLEAR AS IT LOOKS LIKE IT HAS BEEN TRIED TO IMPACT THE LINER NUMEROUS TIMES ON ADJACENT PLACES. THE INDENTS CAUSED BY THE SPIKES APPEAR PAIRED AND ALIGNED, HOWEVER NOT IN SYMMETRY WITH THE CENTER OF THE PE INSERT SPHERE. THE PEG AT THE BOTTOM SURFACE OF INSERT FOR CENTERING THE INLAY IS DEFORMED AND HAS SCRATCHES AT THE TIP. TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WAS MEASURED AND COMPARED WITH THE RESPECTIVE DRAWING. THE CHARACTERISTIC NO. 16 FEATURE "DIAMETER" WAS ACCORDING TO THE DRAWING SPECIFICATIONS. THE OTHER CHARACTERISTICS WERE NOT TAKEN INTO CONSIDERATION SINCE THE POLE PLUG OF THE LINER WAS SIGNIFICANTLY DEFORMED DURING THE OPERATION. NO FUNCTIONAL TEST WAS PERFORMED AS THE PEG IS DEFORMED TO ALLOW A CORRECT POSITION WITHIN THE PLUG. REVIEW OF PRODUCT DOCUMENTATION: INSPECTION PLAN (DURASUL ALPHA INSERT): CHARACTERISTIC NO. 16 FEATURE "DIAMETER" BY 100% QUALITATIVE INSPECTION WITH GAGE, QUANTITATIVE INSPECTION AQL 0.65, AUTOMATED INSPECTION AQL 1.0. MEANS OF INSPECTION: 3D-MESSMASCHINE. CHARACTERISTIC NO. 31 FEATURE ¿DISTANZ BASISFLÄCHE ZU POLABSCHLUSS¿ BY VISUAL INSPECTION AQL 1.0, QUANTITATIVE INSPECTION AQL 2.5 INSPECTION. MEANS OF INSPECTION: 3D-MESSMASCHINE. CHARACTERISTIC NO. 38 FEATURE ¿ZAPFENDURCHMESSER¿ BY VISUAL INSPECTION AQL 0.65, QUALITATIVE INSPECTION AQL 1.0, AUTOMATED INSPECTION 2.5. MEANS OF INSPECTION: CALIPER. THE SURGICAL TECHNIQUE FOR ALLOFIT/ALLOFIT-S ALLOCLASSIC ACETABULAR SYSTEM STATES : ¿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 NOT RECEIVED, THEREFORE CANNOT BE EXCLUDED. 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 DAMAGE OF THE POLAR THREAD OF SHELL IS NOT REPORTED. HOWEVER, SINCE THE SHELL WAS NOT RECEIVED FOR THE INVESTIGATION, 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 PAIRED COMPONENTS 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, UNSYMMETRICAL INDENTS DUE TO THE TWO 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 GG/32 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 THE INDENTS ARE NOT SYMMETRICAL TO THE CENTER OF INSERT. 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 NON-SYMMETRICAL DENTS CAUSED BY THE TWO PINS OF THE SHELL) INDICATE AN EXPERIENCED DIFFICULTY WITH CENTERING THE INSERT WITHIN THE SHELL PRIOR TO IMPACTION. IF THE INLAY 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 GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON MARCH 02, 2017. THE MANUFACTURER RECEIVED THE DEVICES, INVESTIGATION IS ONGOING. X-RAYS OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4). DEVICE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGERY WAS PLANNED WITH A DURASUL, ALPHA INSERT, GG/32. THE SURGEON REPORTED THAT THE INLAY COULD BE INSERTED BUT HAD NO FIXATION, REMAINED LOOSE IN THE CUP. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITH 10 MINUTES DELAY. NOTE: AS THE EXACT EVENT DATE IS UNKNOWN, THE FIELD WAS LEFT EMPTY.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE EVENT OCCURRED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151498 DURASUL ALPHA INSERT, GG/32 INTER-OP DURASUL ACETABULAR INSERTS LPH ZIMMER GMBH N/A 2882169

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other