BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT ALLOCLASSIC SHELL

    MDR report key: 8163773 · Received December 14, 2018

    Report

    Report Number
    0009613350-2018-01199
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    October 16, 2018
    Report Date
    March 10, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    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. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: DHR REVIEW: AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DO NOT FIT OR FUNCTION EVENT DESCRIPTION: IT WAS REPORTED THAT THE A DURASUL LINERS COULD NOT BE ANCHORED IN THE SHELL. THE SHELL REMAINED IN PATIENT, A NEW LINER WAS USED. IT IS UNCLEAR WHETHER THE POLE PLUG WAS USED WITH THE NEW LINER. THE SURGICAL DELAY IS 15 MINS. THIS IS ONE OF THE SIMILAR EVENTS HAPPEND IN KMG KLINIKUM PRITZWALD. DR. AST REPORTED THAT TWO SIMILAR EVENTS HAPPENED WITHIN 2 WEEKS(B)(4). THAT THE IMPLANT DO NOT ANCHOR. NEW LINER WAS IMPLANTED WITHOUT THE SHELL POLE PLUG. THE SURGEON HAS THE IMPRESSION THAT THE DEPTH OF POLE PLUG IS SHALLOW FOR THE PEG OF LINER TO SEAT IN. SIMILAR EVENTS HAD HAPPENED TO OTHER SURGEONS IN THE SAME HOSPITAL: (B)(4). REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICE ANALYSIS: - VISUAL EXAMINATION: THE DURASUL LINER WAS RETURNED FOR INVESTIGATION. MARKS OF THE SETTING TOOL CAN BE SEEN ON THE RIM. A SET OF CLAMP MARK PRESENT ON THE EDGE OF THE RIM.ANOTHER POINT CUT IS OBSERVED ON THE RIM. THE OUTER SURFACE SHOWS SOME LIGHT INDENT AND LIGHT SCRATCHES. A SIGNIFICANT CIRCULAR CUT LOCATE ON THE OUTER SURFACE AND SMALL CUT ON THE POLE PEG WAS OBSERVED. THE CUT ON THE PEG COULD BE RESULTED FROM THE HANDLING OR SLIGHT MALALIGNMENT TO THE POLE PLUG WHEN INSERTING. THE CIRCULAR CUT SHOWS THE LINER WAS ROTATED AFTER THE LINER HAD BEEN IMPACTED INTO THE SPIKE ON THE CUP. - MEASUREMENTS: IT WAS REPORTED THAT THE PRODUCTS WERE AUTOCLAVED BEFORE RETURNING, DUE TO THE HIGH TEMPERATURE, THE DIMENSIONS CAN NO LONGER REFLECTING THE STATE DURING THE EVENT. NEVERTHELESS, THE RELEVANT DIMENSION WAS MEASURED. ACCORDING TO INSPECTION PLAN, RELEVANT CHARACTERISTICS WERE MEASURED WITH CALIPER Z 7568. CHARACTERISTIC NO. 16 FEATURE DIAMETER (46.69MM +0.05/-0.05) -SPECIFICATION: MAX.46.74 MM; MIN. 46.64 MM -MEASURED VALUE: 46.54/46.77 MM (ON DIFFERENT LOCATION) CHARACTERISTIC NO. 11 FEATURE DIAMETER (46.37MM +0.05/-0.05) -SPECIFICATION: MAX.46.42 MM; MIN. 46.32 MM -MEASURED VALUE: 46.18/46.39 MM (ON DIFFERENT LOCATION) CHARACTERISTIC NO. 32 FEATURE DIMENSION (4.0MM +0.1/-0.1) -SPECIFICATION: MAX.4.1 MM; MIN. 3.9 MM -MEASURED VALUE: 4.03 MM CHARACTERISTIC NO. 38 FEATURE DIMENSION (4.6MM +0.1/-0.1) -SPECIFICATION: MAX.4.7 MM; MIN. 4.5 MM -MEASURED VALUE: 4.69 MM -COMMENT: THE LINER WERE SLIGHTLY DEFORMED INTO OVAL SHAPE. HOWEVER, IT IS UNCLEAR WHETHER IT IS RESULTED FROM THE HANDLING, INSERTION OR AUTOCLAVE. REVIEW OF PRODUCT DOCUMENTATION: - THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS THE ITEM NUMBER OF THE SHELL IS UNKNOWN. - LINER INSPECTION: - CHARACTERISTIC NO. 16 FEATURE DIAMETER (46.69MM +0.05/-0.05) WITH SCOPE OF TESTING: AQL 1.0. MEANS OF INSPECTION: 3D MEASURING PROGRAM - CHARACTERISTIC NO. 17 FEATURE DIAMETER (46.63MM +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 SIZE OF INVOLVED SHELL IS UNKNOWN, THEREFORE REVIEW OF CORRESPONDING INSPECTION PLAN COULD NOT BE PERFORMED. - SURGICAL TECHNIQUE: 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. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW (SHELL): - 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 (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. FURTHER, THE LINER HAS SLIGHTLY DEFORMED INTO OVAL SHAPE. - INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE ASSEMBLY FORCE , LEADING TO WRONG ALIGNED INLAYS NOT POSSIBLE, AS THE MARKS FROM SETTING INSTRUMENT IS HOMOGENEOUS. - 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 NOT POSSIBLE, AS THE MARKS FROM SETTING INSTRUMENT IS HOMOGENEOUS. - INTRAOPERATIVE COMPLICATIONS DUE TO WRONG ALIGNMENT OF INSERT IN SHELL => POSSIBLE, AS A SMALL CUT WAS OBSERVED ON THE POLE PEG. - INTRAOPERATIVE COMPLICATIONS DUE TO WRONG POSITIONED INSERT IN SHELL => POSSIBLE, AS A SMALL CUT WAS OBSERVED ON THE POLE PEG. - INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE => POSSIBLE, AS A CIRCULAR CUT FROM THE SHELL SPIKE WAS OBSERVED WHICH IMPLIES EXCESSIVE PRIMARY IMPACTION FORCE AND TORQUE. - INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE => POSSIBLE, AS A CIRCULAR CUT FROM THE SHELL SPIKE WAS OBSERVED WHICH IMPLIES EXCESSIVE PRIMARY IMPACTION FORCE AND TORQUE. - INTRAOPERATIVE COMPLICATIONS DUE TO LACK OF ADEQUATE IMPACTION FORCE => POSSIBLE, AS PARTIALLY FITTED SNAP GEOMETRY IS POSSIBLE DUE TO LACK OF IMPACTION FORCE, ALTHOUGH THE THE CIRCULAR CUT SHOWS THE SPIKES IN THE SHELL HAD BEEN INSERTED INTO THE LINER. CONCLUSION: ONLY THE LINER HAS BEEN RETURNED FOR INVESTIGATION. AS REPORTED, THE LINER HAD BEEN AUTOCLAVED BEFORE RETURNING. THE DIMENSION COULD BE AFFECTED BY THE HIGH TEMPERATURE, THEREFORE COULD NO LONGER REFLECT THE STATE DURING THE EVENT. NEVERTHELESS, THE MEASUREMENT WAS PERFORMED AND SHOWED THE DEFORMATION OF A OVAL SHAPE LINER. IT IS UNCLEAR IF THE DEFORMATION WAS RESULTED FROM THE INSERTION, HANDLING OR THE AUTOCLAVING. 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 A UNUSUAL ROTATIONAL CUT AT THE BOTTOM OF THE LINER. IT INDICATES THE LINER WAS WELL CENTERED, HOWEVER WAS ROTATED WITH HEAVY FORCE AFTER INSERTED BY THE SPIKES OF THE SHELL. THE EXCESSIVE FORCE AND TORQUE APPLIED AFTER CONTACTING THE SHELL SPIKES COULD REDUCE THE ANCHORING STABILITY. MOREOVER, 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 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 THE CONTRIBUTORS PLAYED THE ROLE IN THE COMPLAINT EVENT, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. BASED ON THE AVAILABLE INFORMATION, FURTHER INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE NECESSITY OF POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE REFER TO REPORT 0009613350-2018-01199.

    Additional Manufacturer Narrative · 1

    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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE INLAY COULD NOT BE ANCHORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004677 ALLOFIT ALLOCLASSIC SHELL ALLOFIT ALLOCLASSIC SHELL KWA ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1