BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14

    MDR report key: 6345081 · Received February 21, 2017

    Report

    Report Number
    0009613350-2017-00284
    Event Type
    Injury
    Date Received
    February 21, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 1, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHR): HEAD NUMBER (B)(4) WAS PART OF ORDER #(B)(4) WHICH WAS DISTRIBUTED OVER THE BELOW ZIMMER BIOMET LOTS: LOT: 2880090, LOT: 2881608, LOT: 2881606, LOT: 2881607, LOT: 2881609, LOT: 2880095, LOT: 2881610, LOT: 2882567. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING DFMEA: -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: NO POLAR PLUG DAMAGE IS REPORTED. -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: NO POLAR THREAD OF SHELL IS REPORTED. -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 PELVIS FRACTURE IS REPORTED. -FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG PAIRING OF COMPONENTS (WRONG SIZE) -NOT POSSIBLE: THE USED METALLIC SHELL SHOWS THE CORRECT SIZE/IS MATCHING WITH THE INSERT. -FAILURE OF CONNECTION BETWEEN SHELL AND INSERT (WRONG PAIRING) DUE TO WRONG SELECTION OF PARTS DUE TO UNKNOWN COMPATIBILITY - NOT POSSIBLE: THE PAIRED PARTS ARE COMPATIBLE WITH EACH OTHER. -FAILURE OF CONNECTION BETWEEN SHELL AND INSERT DUE TO WRONG ASSEMBLY PROCEDURE - POSSIBLE: DAMAGES (DEFORMED PEG ON THE INSERT, GROOVES, SCRATCHES AND ABSENCE OF INDENTS INDICATE THE INSERT WAS NOT CENTERED CORRECTLY WITHIN THE SHELL PRIOR TO IMPACTION WITH THE HAMMER. EVENT DESCRIPTION (EVENT DETAILS, PER) - EVENT SUMMARY: IT IS REPORTED THAT AFTER THE THA WAS COMPLETED, WHILE RE-POSITIONING THE PATIENT FROM THE OPERATING TABLE ONTO THE TRANSPORT STRETCHER, DISLOCATION OF THE OPERATED HIP OCCURRED. AFTER RE-OPENING THE SITUS, IT HAS BEEN NOTICED THAT THE INLAY AND HEAD WERE DISLOCATED. NEW INLAY AND HEAD WERE PLACED. NO RECURRENT DISLOCATION OF THE HIP AFTERWARDS. SURGERY EXTENDED 45 MIN. THE SURGEON IS SURE THAT THE CORRECT FIT OF THE INLAY WAS EXTENSIVELY CHECKED DURING THE SURGERY. HE ASSUMES THERE IS AN ERROR IN THE PROPER FIT OF THE INLAY. REVIEW OF RECEIVED DATA: - SURGICAL REPORT DATED (B)(6) 2017: DIAGNOSE: RIGHT COAXARTHROSE OPERATION: ALLOFIT UNCEMENTED SIZE 56 SHELL, DURASUL INLAY SIZE 35, AVENIR UNCEMENTED SIZE 4, 12/14 AND BIOLOX DELTA CERAMIC HEAD SIZE 36 S, 12/14 WERE SELECTED FOR THE OP. AFTER SUCCESSFULLY POSITIONING THE ACETABULAR CUP, STEM AND HEAD, IT HAS BEEN NOTICED THAT THE PE INLAY IS DORSALLY TILTED. HIP IS DISLOCATED. HEAD WAS DIFFICULT TO REMOVE FROM THE STEM. ANOTHER SURGEON IS CONSULTED. SKIN CUT HAS BEEN EXTENDED BY 3-4 CM. FINALLY IT HAS BEEN MANAGED TO REMOVE THE HEAD. INLAY EASILY REMOVED. NEW INLAY AND HEAD WERE PLACED. X-RAYS TAKEN AFTER THE IMPLANTATION SHOWED THE CORRECT POSITIONING OF THE IMPLANTS. NO OTHER ABNORMALITIES NOTICED IN THE SURGICAL REPORT. DEVICES ANALYSIS: - VISUAL EXAMINATION: DURASUL ALPHA INSERT KK/36 (REF:01.00013.711) AND BIOLOX DELTA HEAD (REF: 00-8775-036-01) WERE RECEIVED FOR THE INVESTIGATION. THE ARTICULATING SURFACE OF THE INSERT SHOWS CLEAR CUTS AND MARKS FROM THE SETTING INSTRUMENT. IN THE AREA OF THE SNAP FIT ADDITIONAL SCRATCHES/DENTS CAN BE DETECTED. THE ANCHORING SURFACE OF THE INSERT EXHIBITS SCRATCHES AND GROOVES. NO EVIDENCE OF SHELL-SPIKE SOURCED INDENTS, WHICH WOULD IMPLY A SECURE CONNECTION BETWEEN THE SHELL AND THE INSERT HAS BEEN ESTABLISHED, IS PRESENT. THE OBSERVED GROOVES HAVE BEEN MOST LIKELY CAUSED WHEN THE INLAY WAS ROTATING ON THE SPIKES. THE CENTERING PEG OF THE INSERT IS DEFORMED AND HAS SCRATCHES ON THE TIP SURFACE. BIOLOX DELTA HEAD EXHIBITS METAL TRANSFER OF ERRATIC APPEARANCE IN LARGE AMOUNT ON THE OUTER SURFACE AND ON THE TAPER AREA WHICH CAN BE IDENTIFIED AS SECONDARY EFFECTS. METAL TRANSFER AT THE SURFACE OF THE HEAD IS MOST PROBABLY DUE TO CONTACT BETWEEN THE METALLIC SHELL AND THE CERAMIC HEAD AFTER THE HEAD AND INSERT DISLOCATED. ERRATIC METAL TRANSFER OBSERVED ON THE FACE AND ON THE OUTER CHAMFER OF THE BALL HEAD IS PROBABLY DUE TO THE CONTACT WITH THE METALLIC STEM DURING THE SURGERY. ON THE TAPER AREA OF THE CERAMIC BALL HEAD SYMMETRICAL CONCENTRIC METAL TRANSFER LINES, WHICH WOULD IMPLY A SYMMETRICAL TAPER FIT SITUATION BETWEEN THE CERAMIC HEAD AND THE METAL STEM, CANNOT BE OBSERVED. INSTEAD NON-CONTINUOUS METAL TRANSFER LINES OF ERRATIC APPEARANCE ARE PRESENT, WHICH INDICATES A POSSIBLE MISALIGNED HEAD ON THE METALLIC STEM. - TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED WITH THE CALIPER Z 7568 AND COMPARED WITH THE RESPECTIVE DRAWING. CHARACTERISTIC NO. 16 FEATURE "DIAMETER" -SPECIFICATION: 50.69 +0.05/-0.05 MM, -MEASURED VALUE: 50.69 MM, THE CONDUCTED MEASUREMENTS CONFIRM THE CORRECT SIZE OF THE AFFECTED LINER. 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. - THE SURGICAL TECHNIQUE FOR ALLOFIT/ALLOFIT-S ALLOCLASSIC ACETABULAR STATES THAT ¿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 MIS-POSITIONING, 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.¿ CONCLUSION SUMMARY: REVIEW OF THE DHR OF RETURNED INSERT WITH SIZE KK/36 INDICATES THAT THE DEVICES MET ALL REQUIREMENTS TO PERFORM AS INTENDED. MOREOVER, THE CORRECT SIZE CAN BE CONFIRMED. NO PROBLEMS RELATED INSERT WERE OBSERVED. THE NON-SYMMETRICAL METAL TRANSFER LINES ON THE TAPER AREA OF THE CERAMIC HEAD INDICATES MISALIGNMENT. IN THE CASE OF A SYMMETRICAL TAPER FIT SITUATION BETWEEN THE CERAMIC HEAD AND THE METAL STEM, SYMMETRICAL CONCENTRIC METAL TRANSFER LINES SHOULD BE PRESENT ON THE TAPER AREA. THE VISUAL EXAMINATION OF THE DURASUL ALPHA INSERT SHOWED THAT THERE ARE NO PAIRED INDENTS PRESENT. IN CASE THE INSERT IS CORRECTLY SEATED IN THE METALLIC SHELL, TWO ALIGNED INDENTS SHOULD BE VISIBLE DUE TO THE CONTACT WITH THE SPIKES OF THE SHELL. THIS MEANS THAT DURING THE SURGERY IT WAS NOT POSSIBLE TO IMPACT THE INSERT IN THE SHELL CORRECTLY. FURTHER THE GROOVES INDICATE THE INSERT WAS ROTATED ON THE SPIKES OF THE SHELL. 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. THE CORRECT WAY TO SEAT THE INLAY WITHIN THE SHELL IS EXPLAINED IN THE SURGICAL TECHNIQUE. FURTHER POSSIBLE CAUSES FOR THE REPORTED FAILURE INCLUDE THE SLIGHT DEFORMATION OF THE METALLIC SHELL DUE TO THE VERY HARD BONE CONDITIONS, SOFT TISSUE AND/ OR DEBRIS LEFT BETWEEN INSERT AND CUP PRIOR TO SEATING AND STORING THE INSERT IN A RATHER COLD PLACE WHICH MIGHT LEAD TO A SLIGHT DECREASE OF THE OUTER DIAMETER (MATERIAL REDUCTION). HOWEVER, IT IS NOT KNOWN 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 (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. IT WAS MENTIONED BY COMPLAINANT, THAT THE DEVICES WILL BE RETURNED FOR INVESTIGATION. AS NO LOT NUMBERS WERE PROVIDED FOR THE PRODUCT THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX HEAD IMPLANT ON (B)(6) 2017. DURING RE-POSITIONING OF THE PATIENT AFTER SURGERY FROM THE OPERATING TABLE ONTO THE TRANSPORT STRETCHER, A LUXATION OF THE OPERATED HIP WAS NOTICED. AFTER RE-OPENING OF THE SITUS A LUXATED INLAY AND LUXATED BIOLOX HEAD WERE NOTICED. A NEW INLAY AND HEAD WERE USED WITHOUT REPEATED LUXATION . ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128353 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention