DURASUL, ALPHA INSERT, KK/36
Report
- Report Number
- 0009613350-2018-00322
- Event Type
- Malfunction
- Date Received
- March 6, 2018
- Date of Event
- February 8, 2018
- Report Date
- June 18, 2018
- Manufacturer
- ZIMMER GMBH
- Product Code
- LZO
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: ASSEMBLY ISSUE CUP/LINER, DISLOCATION. EVENT SUMMARY: IT WAS REPORTED THAT DURING REPOSITIONING THE INLAY WAS LUXATED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS 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. INSPECTION PLAN (DURASUL ALPHA INSERT) : CHARACTERISTIC NO.16 FEATURE "DIAMETER" BY 100% QUALITATIVE INSPECTION WITH GAUGE, QUANTITATIVE INSPECTION AQL 0.65, AUTOMATED INSPECTION AQL 1.0. MEANS OF INSPECTION: 3D-MEASURING MACHINE CHARACTERISTIC NO.31 FEATURE ¿DIMENSION: DISTANCE BASE TO POLE¿ BY VISUAL INSPECTION AQL 1.0, QUANTITATIVE INSPECTION AQL 2.5 INSPECTION. MEANS OF INSPECTION: 3D-MEASURING MECHINE CHARACTERISTIC NO.38 FEATURE "DIAMETER PLUG" BY VISUAL INSPECTION AQL 0.65, QUALITATIVE INSPECTION AQL 1.0, AUTOMATED INSPECTION 2.5. MEANS OF INSPECTION: CALIPER. SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE FOR ALLOFIT/ALLOFIT-S ALLOCLASSIC ACETABULAR SYSTEM STATES THAT ¿BONE OR SOFT TISSUE REMNANTS MUST NOT OVERLAP THE EDGE OF THE TITANIUM SHELL AS THEY MAY PREVENT THE INSERT FROM SNAPPING INTO POSITION. THE SHELL EDGE MUST BE FREE FROM ANY TISSUE AND PARTICULAR ATTENTION MUST BE PAID TO THE POSTERIOR INFERIOR BONY EDGE OF THE ACETABULUM. 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 MISPOSITIONNING, 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: FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO INSUFFICIENT SNAP GEOMETRY => NOT POSSIBLE: A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. DAMAGE OF THE INSERT (CAUSE: IMPACTION DURING IMPLANTATION) DUE TO HIGH LOAD DUE TO IMPACTION DURING PRIMARY IMPLANTATION OR REVISION POSSIBLE: AS NO PRODUCT HAS BEEN RETURNED FOR AN INVESTIGATION, THIS CANNOT BE EXCLUDED. DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF SCREW PLUG POSSIBLE: AS NO PRODUCT HAS BEEN RETURNED FOR AN INVESTIGATION, THIS 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 PLUG POSSIBLE: AS NO PRODUCT HAS BEEN RETURNED FOR AN INVESTIGATION, THIS CANNOT BE EXCLUDED. DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF POLAR THREAD OF SHELL POSSIBLE: AS NO PRODUCT HAS BEEN RETURNED FOR AN INVESTIGATION, THIS 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: NO FRACTURE OF THE PELVIS HAS BEEN REPORTED. FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG PAIRING OF COMPONENTS (WRONG SIZE) NOT POSSIBLE: THE USED ALLOFIT CUP HAS THE CORRECT SIZE/IS MATCHING WITH THE INSERT. FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG ASSEMBLY PROCEDURE POSSIBLE: IT MIGHT BE POSSIBLE THAT THE INSERT WAS NOT CENTERED CORRECTLY WITHIN THE SHELL PRIOR TO IMPACTION WITH THE HAMMER. THE INSTRUCTIONS GIVEN IN THE SURGICAL TECHNIQUE NEED TO BE FOLLOWED. CONCLUSION SUMMARY IT WAS REPORTED THAT DURING REPOSITIONING THE INLAY LUXATED. NEITHER THE INLAY NOR ANY SURGICAL REPORT HAS BEEN AVAILABLE FOR AN INVESTIGATION, THEREFORE THE EVENT COULD NOT BE CONFIRMED. REVIEW OF THE DHR OF RETURNED INSERT WITH SIZE KK/36 INDICATES THAT THE DEVICES MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE CORRECT WAY TO SEAT THE INLAY WITHIN THE SHELL IS EXPLAINED IN THE SURGICAL TECHNIQUE. THE INSERT SHOULD NOT BE ROTATED WITHIN THE SHELL, ONCE IT IS IMPACTED. 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. HOWEVER, AS THE PRODUCT HAS NOT BEEN RETURNED, IT REMAINS UNKNWON 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 BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
CONCOMITTANT MEDICAL PRODUCT: ALLOFIT-S ALLOCLASSIC, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 56/KK, REF#: (B)(4), LOT#: 2922023. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURASUL ALPHA EINSATZ NEUTRAL Ø II/32, K013935) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. IT WAS MENTIONED THAT THE INLAY WAS DISCARDED. 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. FURTHER INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
IT WAS REPORTED THAT THE INLAY LUXATED DURING REPOSITION. A SECOND INLAY WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161811 | DURASUL, ALPHA INSERT, KK/36 | N/A | LZO | ZIMMER GMBH | N/A | 2924358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | ALLOFIT SHELL, ITEM# 4267, LOT# 2922023 |