BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6100589 · Received November 14, 2016

    Report

    Report Number
    0009613350-2016-01357
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 20, 2016
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT YET BEEN RECEIVED FOR INVESTIGATION, BUT IT IS MENTIONED BY COMPLAINANT THAT THEY WILL BE SENT BACK 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¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: A BIOLOX DELTA TAPER LINER, II/36 (REF: 00-8775-010-36, LOT: 2868397), A BIOLOX DELTA TAPER LINER, II/36 (REF: 00-8775-010-36, LOT: 2867118) AND A BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, 36/-3.5, TAPER 12/14 (REF 00-8775-036-01 , THE LOT NUMBERS COULD BE NARROWED DOWN TO THESE 3 ACCORDING TO THE ORDER NUMBER DETECTED ON THE RETURNED PRODUCT: 2863934 OR 2864762 OR 2863932) HAVE BEEN RECEIVED. IT IS REPORTED THAT WHILE INSERTING THE CERAMIC INLAY WITH THE ALLOFIT IT INSTRUMENTS AND BY FOLLOWING THE SURGICAL TECHNIQUE, THE INLAY SEEMS TO FIT CORRECTLY AND ARRANGED WITHIN THE ALLOFIT IT CUP (ALLOFIT-S IT ALLOCLASSIC®, SHELL FOR ACETABULUM, UNCEMENTED, 52/II, REF: 00-8755-052-02 LOT: 2866411) WHICH HAD BEEN IMPLANTED BEFORE. AS THE SURGEON TOUCHED THE INLAY AT THE EDGE OF THE CUP TO CHECK IT, IT FELL OUT OF THE CUP IMMEDIATELY. ANOTHER INLAY WAS OPENED TO ACHIEVE A CORRECT FIXATION OF THE INLAY. ALSO WHILE USING THIS NEW INLAY NO CORRECT FIXATION COULD BE ACHIEVED. SEVERAL ATTEMPTS TO FIX THE INLAY WERE WITHOUT SUCCESS. THE SURGERY WAS CONTINUED WITH A LONGEVITY INLAY (LINER NEUTRAL 36 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL). AFTER ATTACHING A CERAMIC HEAD SIZE MINUS 3.5MM (BIOLOX® DELTA, CERAMIC FEMORAL HEAD, 36/-3.5, TAPER 12/14, REF: 00-8775-036-01 LOT: 3238538) AND FOLLOWING REPOSITIONING, THE STRAP TENSION WAS TOO LOOSE. ANOTHER HEAD SIZE 0MM (BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M¸ 36/0, TAPER 12/14, REF: 00-8775-036-02 LOT: 2861613) WAS OPENED AND THE SURGERY WAS COMPLETED. SURGERY WAS DELAYED BY 16-30 MINUTES. VISUAL EXAMINATION: WITHIN THE BIOLOX LINERS NO IMPERFECTIONS OR DETERIORATIONS ARE VISIBLE. ON THE OUTSIDE BOTH LINERS SHOW SIGNS OF USAGE. IN THE AREA WHERE THEY GET IN CONTACT WITH THE CUP DURING INSERTION, SIGNS OF METAL CONTACT CAN BE FOUND. THE FACT THAT THESE SIGNS CAN BE DETECTED ON SEVERAL PLANES ON THE LINERS INDICATES THAT THEY HAVE BEEN PLACED WITHIN THE CUP SEVERAL TIMES. NO CLEAR CONTACT LINES NEAR THE UPPER EDGE OF THE LINERS CAN BE DETECTED. MEASUREMENTS: TO ENSURE THE BIOLOX DELTA TAPER LINER, II/36 (REF: 00-8775-010-36, LOT: 1182711) HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED. CONCLUSION: THE INNER HEIGHT OF THE INLAY CAN BE CONFIRMED. TO ENSURE THE BIOLOX DELTA TAPER LINER, II/36 (REF: 00-8775-010-36, LOT: 1166753) HAS CORRECT DIMENSIONS, THE RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED. CONCLUSION: THE INNER HEIGHT OF THE INLAY CAN BE CONFIRMED. FURTHER THE DHR INDICATES THAT ALL COMPONENTS MET ALL SPECIFICATIONS. FUNCTIONAL TESTS: FUNCTIONAL TESTS HAVE BEEN DONE USING A ALLOFIT-S IT ALLOCLASSIC®, SHELL FOR ACETABULUM, UNCEMENTED, 52/II (REF: 00-8755-052-02 LOT: 2507675/09) AND A ALLOFIT-S IT ALLOCLASSIC®, SHELL FOR ACETABULUM, UNCEMENTED, 52/II (REF: 00-8755-052-02 LOT: 2507675/03). BOTH RECEIVED INLAYS HAVE BEEN PLACED INTO ONE SHELL AND THEN IMPACTED ACCORDING TO THE SURGICAL TECHNIQUE. A TIGHT FIXATION COULD BE ACHIEVED WITH ONE HIT AND THE INLAYS DID NOT FALL OUT AND COULD ALSO NOT BE DETACHED FROM THE SHELL BY HAND. WITH A VERY STRONG ECCENTRIC HIT TO THE EDGE OF THE SHELL THE INLAY COULD BE REMOVED. AFTER REMOVING, THE SHELLS SHOWED SOME ADDITIONAL GREY CONTOUR LINES CLOSE TO THE EDGE OF THE INLAYS. THIS CONTOUR IS AN INDICATOR THAT THE LINER HAS ACHIEVED THE INTENDED POSITION WITHIN THE SHELL WHERE THE FINAL ANCHORING TAKES PLACE. COMPATIBILITY: THE RETURNED HEAD IS COMPATIBLE WITH THE REPORTED LINERS AND THE REPORTED SHELL. THE ST ALLOFIT - S IT ALLOCLASSIC CONTAINS SPECIFIC INFORMATION ABOUT THE HANDLING OF THE BIOLOX LINER: "SELECT THE CORRECT SIZE HARD BEARING RIM IMPACTOR, THAT MATCHES THE IMPLANT HEAD SIZE. ALIGN THE PINS ON THE UNIVERSAL HANDLE WITH THE KEYHOLE SLOT ON THE UNDERSIDE OF THE RIM IMPACTOR. PUSH IT ONTO THE HANDLE AND TWIST IT IN EITHER DIRECTION TO LOCK IT IN PLACE. CENTER THE BIOLOX DELTA LINER BY ROCKING THE IMPACTOR HANDLE PRIOR TO IMPACTION. THIS WILL DECREASE THE LIKELIHOOD OF INCORRECT LINER SEATING. PALPATE AND VISUALLY CHECK THE PERIMETER OF THE SHELL TO ENSURE THAT THE LINER IS NOT CANTED. FIRMLY STRIKE THE UNIVERSAL HANDLE ONCE WITH A MALLET TO FULLY SEAT THE LINER. VERIFY THAT THE LINER IS PROPERLY SEATED. WHEN FULLY INSERTED, IT SHOULD BE FLUSH TO THE FACE OF THE SHELL." CONCLUSION SUMMARY: IT REMAINS UNCLEAR WHY BOTH LINERS DID NOT FIND A TIGHT FIXATION WITHIN THE SHELL. THE RETURNED INLAYS HAVE BEEN PRODUCED ACCORDING SPECIFICATIONS AND THEIR CORRECT SIZES CAN BE CONFIRMED. THE CLEAR MARKS ON THE OUTER SURFACE OF THE INLAYS INDICATE THAT THE LINERS WERE CORRECTLY CENTERED WITHIN THE SHELL PRIOR TO IMPACTION. HOWEVER, THE VISUAL EXAMINATION AND THE FUNCTIONAL TEST INDICATE THAT THE INLAY HAS NOT BEEN IMPACTED COMPLETELY. THE TEST WITH THE INLAYS SHOWED DIFFERENCES REGARDING THE CONTOUR NEAR THE EDGE BETWEEN THE IMPACTION DURING SURGERY AND THE IMPACTION DURING THE FUNCTIONAL TEST. THIS CONTOUR AS VISIBLE AFTER THE FUNCTIONAL TEST IS AN INDICATOR THAT THE LINER HAS ACHIEVED THE INTENDED POSITION WITHIN THE SHELL WHERE THE FINAL ANCHORING TAKES PLACE. POSSIBLE ROOT CAUSES FOR A NON-WELL ANCHORED/ INCOMPLETELY IMPACTED INLAY: SLIGHTLY DEFORMED SHELL (E.G. DUE TO HIGH IMPACTION FORCES IN VERY HARD BONE) MAKING A CORRECT MATCHING AND FIT IN FINAL POSITION MORE DIFFICULT. SOME SOFT TISSUE/DEBRIS/FLUID WAS LOCATED BETWEEN INSERT AND CUP OR PRIOR TO IMPLANTATION. TOO LOW IMPACTION FORCE APPLIED TO TAP THE INLAY IN COMPLETELY. THE SURGICAL TECHNIQUE ST ALLOFIT - S IT ALLOCLASSIC STATES CLEARLY THAT: "FIRMLY STRIKE THE UNIVERSAL HANDLE ONCE WITH A MALLET TO FULLY SEAT THE LINER. VERIFY THAT THE LINER IS PROPERLY SEATED. WHEN FULLY INSERTED, IT SHOULD BE FLUSH TO THE FACE OF THE SHELL." AS NO CLEAR CONTOUR ON THE LINERS COULD BE IDENTIFIED, THE MOST LIKELY ROOT CAUSE IS A TOO LOW IMPACTION FORCE. REGARDING THE COMPLAINT OF THE CERAMIC HEAD, IT IS STATED THAT AFTER ATTACHING A CERAMIC HEAD SIZE MINUS 3.5MM AND FOLLOWING REPOSITIONING, THE STRAP TENSION WAS TOO LOOSE. AFTER SWITCHING FROM THE CERAMIC LINERS TO A LONGEVITY POLY INLAY A TRIAL REDUCTION SHOULD HAVE BEEN DONE TO ENSURE THE RIGHT HEAD SIZE/DISTANCE. THE RETURNED HEAD MIGHT ALREADY HAVE BEEN UNPACKED BASED ON THE ORIGINAL SURGICAL PLANNING AND BEFORE THE DIFFICULTIES WITH THE LINERS OCCURRED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED WHILE INSERTING THE BIOLOX CERAMIC HEAD WITH THE ALLOFIT IT INSTRUMENTS AND BY FOLLOWING THE SURGICAL TECHNIQUE, THE INLAY SEEMS TO FIT CORRECTLY AND ARRANGED WITHIN THE ALLOFIT IT CUP WHICH HAD BEEN IMPLANTED BEFORE. AS THE EXPERIENCES SURGEON TOUCHED THE INLAY AT THE EDGE OF THE CUP TO CHECK IT, IT FELL OUT OF THE CUP IMMEDIATELY. ANOTHER INLAY WAS OPENED TO ACHIEVE A CORRECT FIXATION OF THE INLAY. ALSO WHILE USING THIS NEW INLAY NO CORRECT FIXATION COULD BE ACHIEVED. SEVERAL ATTEMPTS TO FIX THE INLAY WERE WITHOUT SUCCESS. THE SURGERY WAS CONTINUED WITH A LONGEVITY INLAY. AFTER ATTACHING A CERAMIC HEAD SIZE MINUS 3.5MM AND FOLLOWING REPOSITIONING, THE STRAP TENSION WAS TOO LOOSE. ANOTHER HEAD SIZE 0MM WAS OPENED AND THE SURGERY WAS COMPLETED. THE SURGERY WAS DELAYED FOR 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749960 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 75 YR