BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, II/36

    MDR report key: 7555857 · Received May 31, 2018

    Report

    Report Number
    0009613350-2018-00559
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 3, 2018
    Report Date
    October 19, 2018
    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 · 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: INLAY DOES NOT FIT IN THE SHELL. EVENT SUMMARY: IT IS REPORTED THAT THE INLAY COULD NOT BE FIXED INTO THE CUP. ANOTHER INLAY COULD BE FIXED WELL IN THE CUP. A DELAY OF 5 MINUTES OCCURRED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: A DURASUL ALPHA INLAY WAS RECEIVED FOR THE INVESTIGATION OF THE CASE. VISUAL EXAMINATION SHOWED NO SIGNIFICANT DEFORMATIONS PRESENT ON THE INLAY. MINOR SCRATCHES ARE SLIGHTLY OBSERVED AT THE RIM OF THE INLAY. THE IMPRINTS THAT NEED TO BE OBSERVED ON THE ANCHORING SURFACE OF THE INLAY COMING FROM THE CONTACT WITH THE SPIKES OF THE METALLIC SHELL, WHICH WOULD CONFIRM THE SECURE FIXING OF THE INLAY WITHIN THE SHELL, ARE NOT VISIBLE. ONLY ONE SLIGHT IMPRINT IS SEEN, WHICH INDICATES THAT THE INLAY WAS NOT INSERTED WITH AN APPROPRIATE FORCE ACTING ON IT. TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN WERE MEASURED WITH THE MICROMETER. CHARACTERISTIC NO. 11 FEATURE ¿DIAMETER 46.37 +0.05/-0.05¿; SPECIFICATION: MAX. 46.42MM; MIN. 46.32MM; MEASURED VALUE: 46.36 MM. CONCLUSION: THE OUTER DIAMETER OF THE INSERT CAN BE CONFIRMED. CHARACTERISTIC NO. 16 FEATURE ¿DIAMETER 46.69 +0.05/-0.05¿; SPECIFICATION: MAX. 46.74MM; MIN. 46.64MM; MEASURED VALUE: 46.68MM. CONCLUSION: THE SNAP FIT DIAMETER OF THE INSERT CAN BE CONFIRMED. CHARACTERISTIC NO. 31 FEATURE ¿DIMENSION 16.5 +0.05/-0.05¿; SPECIFICATION: MAX. 16.55MM; MIN. 16.45MM; MEASURED VALUE: 16.49 MM. CONCLUSION: THE HEIGHT OF THE INSERT CAN BE CONFIRMED. 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. 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 POSITIONING, NONCONCENTRIC, OR SOFT TISSUES INTERFERENCE BETWEEN THE LINER AND THE SHELL SURFACES. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE ASSEMBLY FORCE , LEADING TO WRONG ALIGNED INLAYS NOT POSSIBLE -> ABSENCE OF BOTH SPIKE IMPRINTS ON THE ANCHORING SURFACE EXCLUDES THAT. 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, ABSENCE OF BOTH SPIKE IMPRINTS ON THE ANCHORING SURFACE CONFIRMS THAT. INTRAOPERATIVE COMPLICATIONS DUE TO WRONG ALIGNMENT OF INSERT IN SHELL => POSSIBLE, PRESENCE OF ONLY ONE SLIGHT IMPRINT CONFIRMS THE WRONG ALIGNMENT. INTRAOPERATIVE COMPLICATIONS DUE TO WRONG POSITIONED INSERT IN SHELL => POSSIBLE, PRESENCE OF ONLY ONE SLIGHT IMPRINT CONFIRMS THE WRONG ALIGNMENT. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE NOT POSSIBLE -> ABSENCE OF IMPRINTS ON THE ANCHORING SURFACE EXCLUDES THAT. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE NOT POSSIBLE -> ABSENCE OF IMPRINTS ON THE ANCHORING SURFACE EXCLUDES THAT. INTRAOPERATIVE COMPLICATIONS DUE TO LACK OF ADEQUATE IMPACTION FORCE => POSSIBLE, ABSENCE OF IMPRINTS ON THE ANCHORING SURFACE CONFIRMS THAT. CONCLUSION SUMMARY: ACCORDING THE INFORMATION AVAILABLE, THE INLAY COULD NOT BE SEATED WITHIN THE SHELL DURING THE OPERATION. RAW MATERIAL CERTIFICATE CONFIRMS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. SIZE MEASUREMENT OF THE RETURNED INSERT SIZE II/36 CONFIRMS THE CORRECT SIZE OF THE DEVICE ACCORDING THE SPECIFICATIONS. THE FACT THAT THE SECOND INLAY SEATED WELL WITHIN THE SHELL INDICATES THAT THERE WAS NOTHING WRONG WITH THE ALLOFIT SHELL. THUS, ANY POSSIBLE RISKS/CAUSES WHICH MIGHT STEM FROM THE SHELL IS NOT CONSIDERED FOR THIS EVENT. MOST LIKELY ROOT CAUSES LEADING TO THE REPORTED FAILURE INCLUDE USER ERRORS SUCH AS THE LACK OF ADEQUATE IMPACTION FORCE APPLIED ON THE INLAY, USE OF UNCLEAN MATING FACES LEADING TO WRONG ALIGNED INLAYS OR LOSS OF INSTRUMENT-IMPLANT CONNECTION AND WRONG POSITIONED INSERT IN SHELL. HOWEVER, 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00806.

    Additional Manufacturer Narrative · 0

    H3: THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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). THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00806.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (.E.: REF:01.00013.409, K013935 ) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW BUT IT WAS MENTIONED BY COMPLAINANT THAT IT WILL BE RETURNED. X-RAYS OR OTHER SOURCE DOCUMENTS WERE NOT PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INLAY COULD NOT BE FIXED INTO THE CUP DURING SURGERY. ANOTHER INLAY COULD BE FIXED WELL IN THE CUP. THE SURGERY WAS COMPLETED WITH 5 MINUTES DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399671 DURASUL, ALPHA INSERT, II/36 DURASUL, ALPHA INSERT LZO ZIMMER GMBH N/A 2928726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ALLOFIT SHELL, ITEM# 4265, LOT# 2933342