BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, HOODED, LL/32

    MDR report key: 7450247 · Received April 23, 2018

    Report

    Report Number
    0009613350-2018-00458
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    March 23, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JWH
    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

    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: INSERT CANNOT BE FIXED IN THE CORRESPONDING CUP. EVENT SUMMARY: TWO DURASUL ALPHA INSERTS OF SIZE LL/32 (REF: 01.00013.512 LOT: 2859051 AND REF: 01.00013.512 LOT: 2930863) HAVE BEEN RECEIVED. IT WAS REPORTED THAT THE INLAY COULD NOT BE ANCHORED IN THE ALLOFIT CUP. THE INLAY SEEMED TO BE FIXED WITHIN THE CUP, HOWEVER, IT LOOSENED AGAIN DURING REPOSITIONING. THREE ADDITIONAL ATTEMPS WITH THREE DIFFERENT NEW INLAYS WERE NECESSARY UNTIL, FINALLY, THE FOURTH INLAY COMPLETELY ANCHORED IN THE SHELL AS INTENDED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS - VISUAL EXAMINATION: INLAY 1 (REF: 01.00013.512 LOT: 2930863): THE INLAY SHOWS A DEFORMED PEG AND SOME DISTINCT SCRATCHES ON THE OUTSIDE AREA. ADDITIONALLY, THERE ARE SCRATCHES ON THE RIM AREA AND IMPRINTS FROM THE IMPACTOR INSTRUMENT. SCRATCHES ARE ALSO SEEN ON THE INNER SURFACE. INLAY 2 (REF: 01.00013.512 LOT: 2859051): THE INLAY SHOWS A CLEARLY DEFORMED PEG AND DISTINCT SCRATCHES ON THE OUTER SURFACE. THERE ARE SCRATCHES AND IMPRINTS FROM THE IMPACTOR INSTRUMENT ON THE RIM AREA AND A DEEP CUT ON THE INNER SURFACE. - MEASUREMENTS: TO ENSURE THE INSERTS HAVE CORRECT DIMENSIONS, RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED WITH A CALIPER. INLAY 1 (REF: 01.00013.512 LOT: 2930863): CHARACTERISTIC NO. 02 FEATURE ¿DIAMETER 52.63 +0.05/-0.05¿ -SPECIFICATION: MAX. 52.68MM; MIN.52.58 MM -MEASURED VALUE: 52.64MM -CONCLUSION: THE SNAP FIT GEOMETRY CAN BE CONFIRMED. CHARACTERISTIC NO. 03 FEATURE ¿DIAMETER 52.37 +0.05/-0.05¿ -SPECIFICATION: MAX. 52.42MM; MIN. 52.32MM -MEASURED VALUE: 52.36MM -CONCLUSION: THE OUTER DIAMETER OF THE INSERT CAN BE CONFIRMED. INLAY 2 (REF: 01.00013.512 LOT: 2859051): CHARACTERISTIC NO. 02 FEATURE ¿DIAMETER 52.63 +0.05/-0.05¿. -SPECIFICATION: MAX. 52.68MM; MIN.52.58 MM. -MEASURED VALUE: 52.66MM. -CONCLUSION: THE SNAP FIT GEOMETRY CAN BE CONFIRMED. CHARACTERISTIC NO. 03 FEATURE ¿DIAMETER 52.37 +0.05/-0.05¿. -SPECIFICATION: MAX. 52.42MM; MIN. 52.32MM. -MEASURED VALUE: 52.32MM. -CONCLUSION: THE OUTER DIAMETER OF THE INSERT CAN BE CONFIRMED. REVIEW OF PRODUCT DOCUMENTATION: - COMPATIBILITY: NO COMPATIBILITY CHECK CAN BE PERFORMED AS THE SHELL AND THE USED INSTRUMENTS HAVE NOT BEEN REPORTED. - INSPECTION PLAN: - CHARACTERISTIC NO. 02 FEATURE ¿DIAMETER (52.69 +0.05/-0.05)¿ WITH SCOPE OF TESTING: AQL 0.65. MEANS OF INSPECTION: 3D MEASURING MACHINE - CHARACTERISTIC NO. 03 FEATURE ¿DIAMETER (52.37 +0.05/-0.05)¿ WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: 3D MEASURING MACHINE - CHARACTERISTIC NO. 05 FEATURE ¿DIMENSION (29.2 +0.2/-0.2 ) WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: ALTIMETER - CHARACTERISTIC NO. 45 FEATURE ¿DIMENSION (4 +0.1/-0.1)¿ WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: KONTURLEHRE - CHARACTERISTIC NO. 51 FEATURE ¿DIAMETER (4.6 +0.1/-0.1) WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: 3D MEASURING MACHINE - SURGICAL TECHNIQUE LINER INSERTION THE POLE PLUG ALLOWS APPROPRIATE FITTING WITH THE POLYETHYLENE LINER PEG. 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. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING DFMEA: - DAMAGE OF THE INSERT (CAUSE: IMPACTION DURING IMPLANTATION) DUE TO HIGH LOAD DUE TO IMPACTION DURING PRIMARY IMPLANTATION OR REVISION POSSIBLE: AS BOTH INLAYS SHOW DEFORMATIONS OF THE PEG, FORMED UPON IMPACTION OF A MISALIGNED INLAY. - DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF SCREW PLUG NOT POSSIBLE: AS NEITHER THE USAGE NOR A DAMAGE OF A SCREW PLUG HAS BEEN REPORTED. - 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 NEITHER A DAMAGE NOR AN EXCHANGE OF THE POLAR PLUG HAS BEEN REPORTED. - DIFFICULTIES TO ASSEMBLE INSERT DUE TO HIGH LOAD DUE TO IMPACTION DURING PRIMARY IMPLANTATION OR REVISION LEADING TO DAMAGE OF POLAR THREAD OF SHELL NOT POSSIBLE: AS NOTHING INDICATES A DAMAGE OF THE POLAR THREAD OF THE SHELL. - 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 FRACTURE OF THE PELVIS OCCURRED. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO INSUFFICIENT SNAP GEOMETRY => NOT POSSIBLE: AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG PAIRING OF COMPONENTS (WRONG SIZE) => NOT POSSIBLE: AS NOTHING INDICATES A PAIRING OF COMPONENTS WITH A WRONG SIZE. - 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 COMBINATION OF INCOMPATIBLE COMPONENTS. - FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG ASSEMBLY PROCEDURE POSSIBLE: AS BOTH INLAYS SHOW DEFORMATIONS OF THE PEG, FORMED UPON IMPACTION OF A MISALIGNED INLAY. CONCLUSION SUMMARY BASED ON THE TWO RECEIVED INLAYS AND THE GIVEN INFORMATION THE COMPLAINT COULD BE CONFIRMED. THE VISUAL EXAMINATION AND THE FUNCTIONAL TESTS DID CONFIRM THAT THE DEFORMED INLAYS IN THEIR CURRENT STATES CANNOT BE ANCHORED IN THE SHELL AS INTENDED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. HOWEVER, IN THE CASE OF A MISALIGNMENT OF THE INLAY WITHIN THE SHELL UPON IMPACTION THE POLAR PEG OF THE INLAY WILL GET DEFORMED TO SUCH AN EXTENT THAT THE INLAY CAN NO LONGER BE WELL ANCHORED. THEREFORE, THE CORRECT POSITIONING OF THE POLAR PEG OF THE INLAY AND THE THE POLAR PLUG OF THE SHELL PRIOR TO IMPACTION IS ESSENTIAL IN ORDER TO OBTAIN A FIRM SEAT OF THE INLAY WITHIN THE SHELL. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE IS A MISALIGNMENT OF THE INSERTS WITHIN THE SHELL PRIOR TO IMPACTION. 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).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: DURASUL, ALPHA INSERT, HOODED, LL/32, ITEM #: 01.00013.512, REF#: (B)(4). THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURASUL ALPHA INSERT NEUTRAL, K013935) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT:0009613350-2018-00457. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    DURING THE SURGERY, SURGEON WAS NOT ABLE TO FIT THE LINER TO THE CUP. AFTER 3 ATTEMPTS WITH DIFFERENT INLAYS, SURGERY WAS COMPLETED WITH 4TH INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292692 DURASUL, ALPHA INSERT, HOODED, LL/32 DURASUL, ALPHA INSERT JWH ZIMMER GMBH N/A 2859051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other