BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, II/36

    MDR report key: 6746308 · Received July 27, 2017

    Report

    Report Number
    0009613350-2017-01003
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 6, 2017
    Report Date
    June 6, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF# AND LOT# OF THE CUP WERE RECEIVED ON MAY 16, 2018. THEREFORE THIS FOLLOW UP REPORT HAS BEEN CREATED. CONCOMITANT MEDICAL PRODUCTS ACCORDING: TEM: (B)(4) ITEM#: ALLOFIT ALLOCLASSIC SHELL 52/I I LOT#: 2903456. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INLAY DOES NOT FIT IN SHELL. DEVICE HISTORY RECORDS (DHR): LOT: 2889390 REF: (B)(4). - YIELD: 80 - DELIVERED: 80 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. ASSOCIATED PRODUCT: LOT: 2903456 REF: (B)(4) - YIELD: 50 - DELIVERED: 50 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: A DURASUL, ALPHA INSERT, II/36 (REF:(B)(4) LOT:2889390) HAS BEEN RECEIVED. ACCORDING TO THE PER THE SURGEON STATES THAT: "THE INLAY DOES NOT FIT IN SHELL. NEW INLAY FITS." MORE INFORMATION OF THE INCIDENT IS NOT PROVIDED. REVIEW OF RECEIVED DATA: - NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: - THE INSERT OF SIZE II/36 WHICH ACCORDING TO THE SURGEON COULD FIT IN THE CUP HAS BEEN RETURNED. VISUAL EXAMINATION: FOR THE DURASUL, ALPHA INSERT, II/36 (REF:01.00013.709; LOT:2889390): THE EXTERIOR SURFACES PRESENTS MULTIPLE SCRATCHES/ DENTS. MOST NOTICEABLE IS A DEEP GROOVE WHICH PROVES THE INLAY HAS BEEN IN DIRECT CONTACT WITH AND ROTATED ON THE TWO SMALL SPIKES WHICH CAN BE FOUND WITHIN THE SHELL. THE PEG ON THE OUTER SURFACE FOR CENTERING THE INLAY IS STILL IN PLACE BUT SCRATCHED AND SLIGHTLY DEFORMED. ON TOP OF THE INLAY IMPRINTS OF THE IMPACTOR CAN BE DETECTED. WITHIN THE INSERT NO DAMAGE CAN BE DETECTED. ON THE SNAP FIT RING, A DAMAGED/ DEFORMED AREA CAN BE DETECTED. MEASUREMENTS: FOR THE DURASUL, ALPHA INSERT, II/36 (REF:01.00013.709; LOT:2889390): TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED WITH A CALIPER. CHARACTERISTIC NO. 11 FEATURE ¿DIAMETER 46.37 +0.05/-0.05¿ -SPECIFICATION: MAX. 46.42MM; MIN. 46.32MM -MEASURED VALUE: 46.36 MM -CONCLUSION: THE OUTER DIAMETER OF THE INSERT CAN BE CONFIRMED. CHARACTERISTIC NO. 16 FEATURE ¿DIAMETER 46.69 +0.05/-0.05¿ -SPECIFICATION: MAX. 46.74MM; MIN. 46.64MM -MEASURED VALUE: 46.67MM -CONCLUSION: THE SNAP FIT DIAMETER OF THE INSERT CAN BE CONFIRMED. CHARACTERISTIC NO. 31 FEATURE ¿DIMENSION 16.5 +0.05/-0.05¿ -SPECIFICATION: MAX. 16.55MM; MIN. 16.45MM -MEASURED VALUE: 16.47 MM -CONCLUSION: THE HEIGHT OF THE INSERT CAN BE CONFIRMED. FURTHER THE DHR INDICATES THAT ALL COMPONENTS MET ALL SPECIFICATIONS. FUNCTIONAL TESTS: - NO FUNCTIONAL TESTS CAN BE CONDUCTED AS THE PART SHOWS SEVERAL DAMAGES/ IMPERFECTIONS. REVIEW OF PRODUCT DOCUMENTATION COMPATIBILITY: - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE: - THE SURGICAL TECHNIQUE STATES: ¿THE SUPPLIED INSERT IS ATTACHED TO THE SETTING INSTRUMENT, INTRODUCED INTO THE CLEANED SHELL, AND IS CAREFULLY CENTERED. THE POLYETHYLENE PEG MUST BE CENTERED IN THE HOLE OF THE POLAR SCREW. TO DO THIS, USE THE SETTING INSTRUMENT TO POSITION THE INSERT AT THE ENTRANCE PLANE OF THE SHELL. IN THIS POSITION, THE INSERT IS TURNED CLOCKWISE USING THE SETTING INSTRUMENT. IF IT CAN EASILY BE TURNED CONCENTRICALLY, IT IS ONLY TAPPED LIGHTLY WITH A HAMMER¿. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO INSUFFICIENT SNAP GEOMETRY. => NOT POSSIBLE: THE SNAP GEOMETRY WAS CHECKED. FURTHER A SYSTEMATIC ISSUE RELATED TO POTENTIAL DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF COMPLAINT TRENDING. - DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE SCREW PLUG. => NOT POSSIBLE: AS NOTHING INDICATES THAT THE SCREW 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 PLUG. => NOT POSSIBLE: AS NOTHING INDICATES THAT 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. => NOT POSSIBLE: AS NOTHING INDICATES THAT THE POLAR THREAD IS DAMAGED. - 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 NOTHING INDICATES THAT THE PELVIS IS FRACTURED. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG PAIRING OF COMPONENTS (WRONG SIZE). => NOT POSSIBLE: AS NOTHING INDICATES A WRONG SIZED SHELL NOT SUITING THE INLAY WAS USED. ADDITIONALLY, IT IS STATED IN THE PER THAT AN INLAY OF SAME SIZE COULD BE IMPLANTED INTO THE SHELL. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT (WRONG PAIRING) DUE TO WRONG SELECTION OF PARTS DUE TO UNKNOWN COMPATIBILITY => NOT POSSIBLE: AS NOTHING INDICATES A WRONG SIZED SHELL NOT SUITING THE INLAY WAS USED. ADDITIONALLY IT IS STATED IN THE PER THAT AN INLAY OF SAME SIZE COULD BE IMPLANTED INTO THE SHELL. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG ASSEMBLY PROCEDURE. => POSSIBLE: AS THE DAMAGES AND SCRATCHES WHICH CAN BE DETECTED ON THE INSERT INDICATE SOMETHING WENT WRONG DURING THE ASSEMBLY PROCEDURE. MAYBE THE INSERT WAS NOT CENTERED CORRECTLY PRIOR TO IMPACTION. FURTHER AS THE INLAY SHOWS A GROOVE AROUND THE OUTER SURFACE IT CAN BE ASSUMED THAT THE INLAY WAS FIRST IMPACTED AND THEN ROTATED ON THE TWO SMALL SPIKES WHICH CAN BE FOUND DEEP WITHIN THE SHELL. CONCLUSION SUMMARY: BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED HOWEVER AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED INSERT WITH SIZE II/36 HAS BEEN PRODUCED ACCORDING SPECIFICATIONS AND ITS CORRECT SIZE CAN BE CONFIRMED. IT REMAINS UNCLEAR WHY THE INSERT COULD NOT BE ANCHORED WITHIN THE SHELL. THE DAMAGES AND SCRATCHES WHICH CAN BE DETECTED ON THE INSERT INDICATE SOMETHING WENT WRONG DURING THE ASSEMBLY PROCEDURE. MAYBE THE INSERT WAS NOT CENTERED CORRECTLY PRIOR TO IMPACTION. FURTHER AS THE INLAY SHOWS A GROOVE AROUND THE OUTER SURFACE IT CAN BE ASSUMED THAT THE INLAY WAS FIRST IMPACTED AND THEN ROTATED ON THE TWO SMALL SPIKES WHICH CAN BE FOUND DEEP WITHIN THE SHELL. ACCORDING TO THE SURGICAL TECHNIQUE THE INSERT SHOULD BE CENTERED BY TURNING IT CONCENTRICALLY PRIOR TO IMPACTION. 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

    NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: INLAY DOES NOT FIT IN SHELL. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: A DURASUL®, ALPHA INSERT, II/36 (REF:01.00013.709; LOT:2889390) HAS BEEN RECEIVED. ACCORDING TO THE PER THE SURGEON STATES THAT: "THE INLAY DOES NOT FIT IN SHELL. NEW INLAY FITS." MORE INFORMATION OF THE INCIDENT IS NOT PROVIDED. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: THE INSERT OF SIZE II/36 WHICH ACCORDING TO THE SURGEON COULD FIT IN THE CUP HAS BEEN RETURNED. VISUAL EXAMINATION: FOR THE DURASUL®, ALPHA INSERT, II/36 (REF:01.00013.709; LOT:2889390): THE EXTERIOR SURFACES PRESENTS MULTIPLE SCRATCHES/ DENTS. MOST NOTICEABLE IS A DEEP GROOVE WHICH PROVES THE INLAY HAS BEEN IN DIRECT CONTACT WITH AND ROTATED ON THE TWO SMALL SPIKES WHICH CAN BE FOUND WITHIN THE SHELL. THE PEG ON THE OUTER SURFACE FOR CENTERING THE INLAY IS STILL IN PLACE BUT SCRATCHED AND SLIGHTLY DEFORMED. ON TOP OF THE INLAY IMPRINTS OF THE IMPACTOR CAN BE DETECTED. WITHIN THE INSERT NO DAMAGE CAN BE DETECTED. ON THE SNAP FIT RING, A DAMAGED/ DEFORMED AREA CAN BE DETECTED. MEASUREMENTS: FOR THE DURASUL®, ALPHA INSERT, II/36 (REF:01.00013.709; LOT:2889390): TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED WITH A CALIPER. CHARACTERISTIC NO. 11 FEATURE ¿DIAMETER 46.37 +0.05/-0.05¿ SPECIFICATION: MAX. 46.42MM; MIN. 46.32MM. MEASURED VALUE: 46.36 MM. CONCLUSION: THE OUTER DIAMETER OF THE INSERT CAN BE CONFIRMED. CHARACTERISTIC NO. 16 FEATURE ¿DIAMETER 46.69 +0.05/-0.05¿. SPECIFICATION: MAX. 46.74MM; MIN. 46.64MM. MEASURED VALUE: 46.67MM. CONCLUSION: THE SNAP FIT DIAMETER OF THE INSERT CAN BE CONFIRMED. CHARACTERISTIC NO. 31 FEATURE ¿DIMENSION 16.5 +0.05/-0.05¿ SPECIFICATION: MAX. 16.55MM; MIN. 16.45MM. MEASURED VALUE: 16.47 MM. CONCLUSION: THE HEIGHT OF THE INSERT CAN BE CONFIRMED. FURTHER THE DHR INDICATES THAT ALL COMPONENTS MET ALL SPECIFICATIONS. FUNCTIONAL TESTS: NO FUNCTIONAL TESTS CAN BE CONDUCTED AS THE PART SHOWS SEVERAL DAMAGES/ IMPERFECTIONS. REVIEW OF PRODUCT DOCUMENTATION: SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE STATES: ¿THE SUPPLIED INSERT IS ATTACHED TO THE SETTING INSTRUMENT, INTRODUCED INTO THE CLEANED SHELL, AND IS CAREFULLY CENTERED. THE POLYETHYLENE PEG MUST BE CENTERED IN THE HOLE OF THE POLAR SCREW. TO DO THIS, USE THE SETTING INSTRUMENT TO POSITION THE INSERT AT THE ENTRANCE PLANE OF THE SHELL. IN THIS POSITION, THE INSERT IS TURNED CLOCKWISE USING THE SETTING INSTRUMENT. IF IT CAN EASILY BE TURNED CONCENTRICALLY, IT IS ONLY TAPPED LIGHTLY WITH A HAMMER¿. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING FMEA: FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO INSUFFICIENT SNAP GEOMETRY. NOT POSSIBLE: THE SNAP GEOMETRY WAS CHECKED. FURTHER A SYSTEMATIC ISSUE RELATED TO POTENTIAL DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF COMPLAINT TRENDING. DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING THE PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF THE SCREW PLUG. NOT POSSIBLE: AS NOTHING INDICATES THAT THE SCREW 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 PLUG. NOT POSSIBLE: AS NOTHING INDICATES THAT 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. NOT POSSIBLE: AS NOTHING INDICATES THAT THE POLAR THREAD IS DAMAGED. 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 NOTHING INDICATES THAT THE PELVIS IS FRACTURED. FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG PAIRING OF COMPONENTS (WRONG SIZE). NOT POSSIBLE: AS NOTHING INDICATES A WRONG SIZED SHELL NOT SUITING THE INLAY WAS USED. ADDITIONALLY, IT IS STATED IN THE PER THAT AN INLAY OF SAME SIZE COULD BE IMPLANTED INTO THE SHELL. FAILURE OF CONNECTION BETWEEN SHELL AND INSERT (WRONG PAIRING) DUE TO WRONG SELECTION OF PARTS DUE TO UNKNOWN COMPATIBILITY. NOT POSSIBLE: AS NOTHING INDICATES A WRONG SIZED SHELL NOT SUITING THE INLAY WAS USED. ADDITIONALLY IT IS STATED IN THE PER THAT AN INLAY OF SAME SIZE COULD BE IMPLANTED INTO THE SHELL. FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG ASSEMBLY PROCEDURE. POSSIBLE: AS THE DAMAGES AND SCRATCHES WHICH CAN BE DETECTED ON THE INSERT INDICATE SOMETHING WENT WRONG DURING THE ASSEMBLY PROCEDURE. MAYBE THE INSERT WAS NOT CENTERED CORRECTLY PRIOR TO IMPACTION. FURTHER AS THE INLAY SHOWS A GROOVE AROUND THE OUTER SURFACE IT CAN BE ASSUMED THAT THE INLAY WAS FIRST IMPACTED AND THEN ROTATED ON THE TWO SMALL SPIKES WHICH CAN BE FOUND DEEP WITHIN THE SHELL. CONCLUSION SUMMARY: BASED ON THE RETURNED PRODUCT AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED HOWEVER AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED INSERT WITH SIZE II/36 HAS BEEN PRODUCED ACCORDING SPECIFICATIONS AND ITS CORRECT SIZE CAN BE CONFIRMED. IT REMAINS UNCLEAR WHY THE INSERT COULD NOT BE ANCHORED WITHIN THE SHELL. THE DAMAGES AND SCRATCHES WHICH CAN BE DETECTED ON THE INSERT INDICATE SOMETHING WENT WRONG DURING THE ASSEMBLY PROCEDURE. MAYBE THE INSERT WAS NOT CENTERED CORRECTLY PRIOR TO IMPACTION. FURTHER AS THE INLAY SHOWS A GROOVE AROUND THE OUTER SURFACE IT CAN BE ASSUMED THAT THE INLAY WAS FIRST IMPACTED AND THEN ROTATED ON THE TWO SMALL SPIKES WHICH CAN BE FOUND DEEP WITHIN THE SHELL. ACCORDING TO THE SURGICAL TECHNIQUE THE INSERT SHOULD BE CENTERED BY TURNING IT CONCENTRICALLY PRIOR TO IMPACTION. 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).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WANTED TO IMPLANT A DURASUL, ALPHA INSERT, II/36 ON (B)(6) 2017 WHICH DID NOT FIT, THEREFORE ANOTHER ALPHA INSERT WAS USED AND FITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529286 DURASUL, ALPHA INSERT, II/36 JDI ZIMMER GMBH N/A 2889390

    Patients

    Seq Age Sex Outcome Treatment
    1