BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASUL, ALPHA INSERT, HOODED, KK/32

    MDR report key: 7604940 · Received June 15, 2018

    Report

    Report Number
    0009613350-2018-00630
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 24, 2018
    Report Date
    September 18, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    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: IMPLANT DOES NOT FIT. EVENT SUMMARY: DURING A SURGERY ON (B)(6) 2018, THE INLAY DID NOT FIT INTO THE CUP; SURGERY WAS COMPLETED WITH ANOTHER INLAY. NO SURGICAL DELAY HAS BEEN REPORTED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE INLAY SHOWS A DEFORMED PEG AND SOME DISTINCT SCRATCHES ON THE OUTSIDE AREA. ADDITIONALLY, THERE ARE SCRATCHES ON THE RIM AREA. SCRATCHES ARE ALSO SEEN ON THE ANCHORING SURFACE . ON THE ANCHORING SURFACE OF THE INLAY IMPRINTS OF THE SPIKES OF THE METALLIC SHELL CAN BE DETECTED. IMPRINTS SEEM TO BE NOT IN SAME DISTANCE FROM THE POLAR PEG INDICATING A WRONG ALIGNMENT OF THE INLAY WITHIN THE SHELL. POLE PLUG OF THE SHELL IS ALSO RECEIVED. MINOR SCRATCHES ARE OBSERVED ON THE FRONT SURFACE. TO ENSURE THE INSERT HAS CORRECT DIMENSIONS, RELEVANT CHARACTERISTIC ACCORDING TO THE INSPECTION PLAN SAP WERE MEASURED WITH THE MICROMETER. CHARACTERISTIC ¿DIAMETER 50.37 +0.05/-0.05¿; SPECIFICATION: MAX. 50.27MM; MIN.50.42MM; MEASURED VALUE: 50.38MM; CONCLUSION: THE SNAP FIT GEOMETRY CAN BE CONFIRMED. CHARACTERISTIC ¿DIAMETER 50.69 +0.05/-0.05¿; SPECIFICATION: MAX. 50.64MM; MIN. 50.74MM; MEASURED VALUE: 50.68MM; CONCLUSION: THE OUTER DIAMETER OF THE INSERT CAN BE CONFIRMED. REVIEW OF PRODUCT DOCUMENTATION: NO COMPATIBILITY CHECK CAN BE PERFORMED AS THE SHELL AND THE USED INSTRUMENTS HAVE NOT BEEN REPORTED. ACCORDING INSPECTION PLAN FOLLOWING CHARACTERISTICS ARE INSPECTED: CHARACTERISTIC ¿DIAMETER (52.69 +0.05/-0.05)¿ WITH SCOPE OF TESTING: AQL 0.65. MEANS OF INSPECTION: 3D MEASURING MACHINE. CHARACTERISTIC ¿DIAMETER (52.37 +0.05/-0.05)¿ WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: 3D MEASURING MACHINE. CHARACTERISTIC ¿DIMENSION (29.2 +0.2/-0.2 ) WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: ALTIMETER. CHARACTERISTIC ¿DIMENSION (4 +0.1/-0.1)¿ WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: KONTURLEHRE. CHARACTERISTIC ¿DIAMETER (4.6 +0.1/-0.1) WITH SCOPE OF TESTING: FAL. MEANS OF INSPECTION: 3D MEASURING MACHINE. 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 MISPOSITIONNING, 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 => POSSIBLE, IMPRINTS FROM THE SPIKE CONFIRM THE WRONG ALIGNMENT 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, IMPRINTS FROM THE SPIKE CONFIRM THE WRONG ALIGNMENT INTRAOPERATIVE COMPLICATIONS DUE TO WRONG ALIGNMENT OF INSERT IN SHELL => POSSIBLE, IMPRINTS FROM THE SPIKE CONFIRM THE WRONG ALIGNMENT INTRAOPERATIVE COMPLICATIONS DUE TO WRONG POSITIONED INSERT IN SHELL => POSSIBLE, IMPRINTS FROM THE SPIKE CONFIRM THE WRONG ALIGNMENT INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE => POSSIBLE, EXCESSIVE/INADEQUATE FORCE COULD LEAD TO FAIL. INTRAOPERATIVE COMPLICATIONS DUE TO EXCESSIVE IMPACTION FORCE => POSSIBLE, EXCESSIVE/INADEQUATE FORCE COULD LEAD TO FAIL. INTRAOPERATIVE COMPLICATIONS DUE TO LACK OF ADEQUATE IMPACTION FORCE => POSSIBLE, EXCESSIVE/INADEQUATE FORCE COULD LEAD TO FAIL. CONCLUSION SUMMARY: ACCORDING THE EVENT THE INLAY DID NOT FIT INTO THE CUP. 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. MEASUREMENTS CONFIRM THE CORRECT SIZE OF THE PRODUCT. MOST LIKELY ROOT CAUSE OF THE EVENT IS THE WRONG ALIGNMENT OF THE INLAY WITHIN THE METALLIC SHELL. THE IMPRINTS ON THE ANCHORING SURFACE OF THE INLAY COMING FROM THE METALLIC SPIKES OF THE SHELL ALSO CONFIRMS THIS. EXCESSIVE/INADEQUATE FORCE APPLIED ON THE ILAY COULD ALSO LEAD TO THE FAILURE OBSERVED. 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).

    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. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON (B)(6) 2018 TO THE APPROPRIATE REPRESENTATIVES. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(6) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K993259. 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

    IT WAS REPORTED THAT DURING A SURGERY THE DURASUL, ALPHA INSERT, HOODED, KK/32 DID NOT FIT INTO THE CUP. SURGERY WAS COMPLETED WITH ANOTHER INLAY. NO SURGICAL DELAY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447038 DURASUL, ALPHA INSERT, HOODED, KK/32 N/A LPH ZIMMER GMBH N/A 2932416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other POLVERSCHLUSS, ITEM# B20620, LOT# 2938445