BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, HH/32

    MDR report key: 8163840 · Received December 14, 2018

    Report

    Report Number
    0009613350-2018-01214
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 8, 2018
    Report Date
    March 10, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWZ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: ASSEMBLY ISSUE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE A DURASUL LINERS COULD NOT BE ANCHORED IN THE SHELL. IT WAS DISCOVERED DURING INVESTIGATION THAT THE CORRECT REFERENCE NUMBER IS 01.00013.408 AND THE LOT NUMBER IS 2950068. THEREFORE THE COMPLAINT INFORMATION WAS UPDATED ACCORDINGLY. THIS IS ONE OF THE SIMILAR EVENTS HAPPENED IN (B)(6). DR. (B)(6) REPORTED THAT TWO SIMILAR EVENTS HAPPENED WITHIN 2 WEEKS (B)(4) AND (B)(4) THAT THE LINER DID NOT ANCHOR. NEW LINER WAS IMPLANTED WITHOUT THE POLE PLUG. THE SURGEON HAS THE IMPRESSION THAT THE DEPTH OF POLE PLUG IS TOO SHALLOW FOR THE PEG OF LINER TO SEAT IN. SIMILAR EVENTS HAD HAPPENED TO OTHER SURGEONS IN THE SAME HOSPITAL: (B)(4), (B)(4) AND (B)(4)(CURRENT COMPLAINT). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: VISUAL EXAMINATION: THE LINER SHOWS THE ITEM NUMBER IS 01.00013.408 AND LOT IS 2950068. NO INDENT MARK FROM THE IMPACTION TOOL WAS FOUND ON THE RIM. SOME HEAVY CUTS AND INDENTATION FROM CLAMPING ARE OBSERVED ON THE EDGE OF INNER SURFACE. SOME CLAMPING MARKS AND INDENTATIONS ARE VISIBLE ON THE OUTER SURFACE OF THE RIM. THE CLAMPING MARK EXTEND TO THE OUTER SHPERE SURFACE. NO OTHER VISIBLE SIGN OF INDENTATION ON THE OUTER SURFACE IMPLYING THE LINER WAS NOT IN CONTACT WITH THE SPIKE ON THE SHELL. THE POLE PEG IS SLIGHTLY DEFORMED WITH THE TILTED TOP SURFACE ON THE TIP. MEASUREMENTS: IT WAS REPORTED THAT THE PRODUCTS WERE AUTOCLAVED BEFORE RETURNING, DUE TO THE HIGH TEMPERATURE, THE DIMENSIONS CAN NO LONGER REFLECT THE STATE DURING THE EVENT OR THE TIME OF PRODUCTION. HOWEVER, THE REVERENT DIMENSIONS WAS MEASURED. ACCORDING TO INSPECTION PLAN, RELEVANT CHARACTERISTICS WERE MEASURED WITH CALIPER Z 7568. CHARACTERISTIC NO. 16 FEATURE DIAMETER (44.69MM +0.05/-0.05). SPECIFICATION: MAX.44.74 MM; MIN. 44.64 MM. MEASURED VALUE: 44.72/44.75MM (ON DIFFERENT LOCATION). CHARACTERISTIC NO. 11 FEATURE DIAMETER (44.37MM +0.05/-0.05). SPECIFICATION: MAX.44.42 MM; MIN. 44.32 MM. MEASURED VALUE: 44.46/44.38 MM (ON DIFFERENT LOCATION). CHARACTERISTIC NO. 33 FEATURE DIMENSION (4.0MM +0.1/-0.1). SPECIFICATION: MAX.4.1 MM; MIN. 3.9 MM. MEASURED VALUE: 3.79/3.99MM (ON DIFFERENT LOCATION). CHARACTERISTIC NO. 38 FEATURE DIMENSION (4.6MM +0.1/-0.1). SPECIFICATION: MAX.4.7 MM; MIN. 4.5 MM. MEASURED VALUE: 4.70/4.65 MM (ON DIFFERENT LOCATION). COMMENT: THE MEASUREMENT CONFIRMED THE DEFORMED POLE PEG. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS NOT PERFORMED AS THE ITEM NUMBER FOR THE SHELL IS UNKNOWN. LINER INSPECTION PLAN: CHARACTERISTIC NO. 16 FEATURE DIAMETER (44.69MM +0.05/-0.05) WITH SCOPE OF TESTING: AQL 1.0. MEANS OF INSPECTION: 3D MEASURING PROGRAM. CHARACTERISTIC NO. 17 FEATURE DIAMETER (44.63MM +0.05/-0.05) WITH SCOPE OF TESTING: AQL 1.0. MEANS OF INSPECTION: 3D MEASURING PROGRAM. CHARACTERISTIC NO. 38 FEATURE DIMENSION (4.6MM +0.1/-0.1) WITH SCOPE OF TESTING: AQL 1.0. MEANS OF INSPECTION: CALIPER. POLE PLUG INSPECTION PLAN: CHARACTERISTIC NO. 02 FEATURE DIMENSION (5 +0.1/0.0) WITH SCOPE OF TESTING: AQL 2.5. MEANS OF INSPECTION: GAUGE. CHARACTERISTIC NO. 07 FEATURE DIAMETER (4.3 +0.1/0.0) WITH SCOPE OF TESTING: AQL 0.65. MEANS OF INSPECTION: HEIGHT GAUGE. CHARACTERISTIC NO. 08 FEATURE DIAMETER (3.8 +0.1/0.0) WITH SCOPE OF TESTING: AQL 2.5. MEANS OF INSPECTION: GAUGE. THE REF NUMBER OF INVOLVED SHELL IS UNKNOWN, THEREFORE REVIEW OF CORRESPONDING INSPECTION PLAN COULD NOT BE PERFORMED. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW (ALLOTFIT SHELL AND POLE PLUG): FAILURE OF SHELL AND LINER CONNECTION DUE TO INSUFFICIENT SNAP GEOMETRY BETWEEN SHELL AND LINER: NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. DIFFICULT ALPHA LINER INSERTION DUE TO DEFORMATION OF SHELL DUE TO LOAD: POSSIBLE, AS THE CONDITION OF THE SHELL IS UNKNOWN. HOWEVER, A NEW LINER WAS INSERTED INTO THE SAME SHELL, THE POSSIBILITY OF THIS CAUSE IS LOW. INTRAOPERATIVE COMPLICATIONS DUE TO INADEQUATE HANDLING DURING TRANSPORT/STORAGE: POSSIBLE, AS NO SUFFICIENT INFORMATION OF EXCLUDE THIS CAUSE. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE INSERTION FORCE, LEADING TO WRONG ALIGNED POLE PLUG: POSSIBLE, AS THE POLE PLUG HAS NOT BEEN RETURNED; THE CONDITION IS UNKNOWN. INTRAOPERATIVE COMPLICATIONS DUE TO LACK OF INSERTION FORCE AND/OR UNCLEAN MATING FACES ARE USED, LEADING TO WRONG ALIGNED POLE PLUG: POSSIBLE, AS THE POLE PLUG HAS NOT BEEN RETURNED; THE CONDITION IS UNKNOWN. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE OR LACK OF INSERTION FORCE LEADING TO WRONG ALIGNED POLE PLUG: POSSIBLE, AS THE POLE PLUG HAS NOT BEEN RETURNED; THE CONDITION IS UNKNOWN. ROOT CAUSE DETERMINATION USING SAP RMW (DURASUL LINER): LOSS OF INSERT-SHELL CONNECTION, COMPONENT LOOSENING, DISLOCATION DUE TO INSUFFICIENT INSERT STABILITY DUE TO DESIGN (SNAP GEOMETRY) NOT POSSIBLE, AS A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT . INTRAOPERATIVE COMPLICATIONS DUE TO INADEQUATE HANDLING DURING TRANSPORT/STORAGE: POSSIBLE, AS NO SUFFICIENT INFORMATION OF EXCLUDE THIS CAUSE. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE ASSEMBLY FORCE , LEADING TO WRONG ALIGNED INLAYS: NOT POSSIBLE, AS NO MARK OF THE SETTING INSTRUMENT WERE OBSERVED ON THE RIM. ALSO, NO OTHER RELEVANT MARKS FOUND. INTRAOPERATIVE COMPLICATIONS DUE TO LACK OF ASSEMBLY FORCE AND/OR UNCLEAN MATING FACES ARE USED, LEADING TO WRONG ALIGNED INLAYS OR LOSS OF INSTRUMENT-IMPLANT CONNECTION: POSSIBLE, AS NO MARK OF THE SETTING INSTRUMENT WERE OBSERVED ON THE RIM. INTRAOPERATIVE COMPLICATIONS DUE TO WRONG ALIGNMENT OF INSERT IN SHELL: POSSIBLE, AS THE POLE PEG IS SLIGHTLY DEFORMED. INTRAOPERATIVE COMPLICATIONS DUE TO WRONG POSITIONED INSERT IN SHELL: POSSIBLE, AS THE POLE PEG IS SLIGHTLY DEFORMED. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE: NOT POSSIBLE, AS NO SPIKE INDENTATIONS ON THE BOTTOM; THE LINER DID NOT CONTACT THE SHELL SPIKE. INTRAOPERATIVE COMPLICATIONS DUE TO LACK OF ADEQUATE IMPACTION FORCE: POSSIBLE, AS NO SPIKE INDENTATIONS ON THE BOTTOM; THE LINER DID NOT CONTACT THE SHELL SPIKE. CONCLUSION: ONLY THE LINER HAS BEEN RETURNED FOR INVESTIGATION. THE SHELL REMAIN IN PATIENT, BUT IT IS UNCLEAR IF THE POLE PLUG WAS IMPLANTED. THE MEASUREMENT SHOWS THE SLIGHTLY DEFORMED POLE PEG. HOWEVER, AS REPORTED, THE LINER HAD BEEN AUTOCLAVED BEFORE RETURNING. THE DIMENSIONS COULD HAD BEEN AFFECTED BY THE HIGH TEMPERATURE; THEREFORE THEY NO LONGER REFLECTS THE STATE DURING THE EVENT. IT IS UNCLEAR IF THE DEFORMATION WAS RESULTED FROM THE INSERTION, HANDLING OR THE AUTOCLAVING. FURTHER, THE QUALITY RECORDS OF ALL PRODUCTS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE VISUAL EXAMINATION SHOWED THAT THE SPIKE INDENTATIONS ARE MISSING, IMPLYING THE LINER HAD NOT BEEN IN CONTACT WITH THE SHELL SPIKES. IT COULD BE A INDICATION OF LACK OF IMPACTION FORCE OR IMPACTION ON A INADEQUATELY POSITIONED LINER. AS THE SHELL REMAINED IN PATIENT AND THE NEW INLAY WAS SUCCESSFULLY INSERTED, IT IS LESS LIKELY THE SHELL HAVE CONTRIBUTE TO THE EVENT. HOWEVER, IT IS ALSO POSSIBLE THAT THE POLE PLUG WAS NOT ALIGNED OR NOT SCREWED ENTIRELY INTO THE APICAL HOLE LEADING TO REDUCED TOTAL DEPTH FOR LINER TO SEAT IN. OTHER POSSIBLE CAUSE THAT CONTRIBUTE TO THE DIFFICULTY OF LINER INSERTION INCLUDES SUB-OPTIMALLY ASSEMBLED/ALIGNED/POSITIONED INSTRUMENT LEADS TO INEFFICIENT IMPACTION OR WRONG DIRECTION OF FORCE, PRESENCE OF SOFT TISSUE OR DEBRIS BETWEEN CUP/LINER AND SLIGHTLY DECREASED LINER DIAMETER DUE TO RATHER COLD STORAGE ENVIRONMENT. HOWEVER, IT IS UNKNOWN TO WHICH EXTENT EACH CONTRIBUTORS PLAYED THE ROLE IN THE COMPLAINT 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).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2018-01214.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: ALLOFIT CUP HIP IMPL WIN, CATALOG NO#: UNKNOWN; LOT#: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED 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. (B)(4).

    Description of Event or Problem · 1

    PATIENT SUFFERED INTRAOPERATIVE COMPLICATION AS THE INLAY COULD NOT BE ANCHORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003240 DURASUL, ALPHA INSERT, HH/32 N/A KWZ ZIMMER GMBH N/A 2950068

    Patients

    Seq Age Sex Outcome Treatment
    1