BEUDAMED
    FDA Adverse Event Other Summary report: N

    DURASUL LOW PROFILE CUP 50 / 36

    MDR report key: 4901378 · Received July 7, 2015

    Report

    Report Number
    9613350-2015-00721
    Event Type
    Other
    Date Received
    July 7, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 17, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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).

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. REVIEW OF INCOMING INFORMATION: IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE PF STEM WAS CEMENTED AND THE HEAD WAS INSERTED ON THE STEM. HOWEVER, IMPLANTING THE CUP WAS DIFFICULT. THREE ATTEMPTS TO POSITION THE CEMENTED CUP INTO THE ACTABULUM WERE NOT SUCCESSFUL. SURGEON DECIDED TO REMOVE ALL THE DEVICES (CUP, HEAD, STEM). AT THE END OF THE SURGERY THE PATIENT HAD A RESECTION OF THE FEMUR HEAD. SURGERY WAS COMPLETED WITH ""GIRDLESTONE PROCEDURE"". THE PATIENT HAS NO HIP JOINT ANYMORE. NO X-RAYS OR PICTURES, NO SURGICAL, NO OTHER DOCUMENTS WERE PROVIDED DEVICES ANALYSIS: THE PF STEM, BIOLOX DELTA HEAD AND TWO DURASUL LOW PROFILE CUPS WERE RECEIVED FOR THE INVESTIGATION. ALL OF THE IMPLANTS, EXCEPT THE BALL HEAD, ARE COVERED WITH BONE CEMENT. THE FEMORAL HEAD SHOWS SIGNS OF USAGE. ANCHORING SURFACE OF THE HEAD APPEARS TO BE COVERED WITH METAL TRANSFER, WHICH SEEM TO BE UNEXPECTEDLY MORE INTENSE FOR AN IMPLANT WITH NO IN-VIVO TIME. ARTICULATING SURFACE OF THE HEAD IS OBSERVED TO BE INTACT. FEMORAL STEM IS SHOWN TO HAVE SOME SCRATCHES ON THE NECK REGION. ONE OF THE CUPS RECEIVED IS ATTACHED TO A REINFORCEMENT RING WITH HOOK BY THE HELP OF BONE CEMENT. THE OTHER CUP IS ONLY COVERED WITH THE BONE CEMENT. BUT BOTH OF THE CUPS SEEM TO BE FREE OF ANY DEFORMATION ON THE INNER SURFACE OF THEM. REVIEW OF INTERNAL DOCUMENTS: THE CORRECT ASSEMBLY OF THE DURASUL LOW PROFILE CUP IS EXPLAINED IN THE SURGICAL TECHNIQUE FOR (B)(6) LOW PROFILE CUP. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: LINE 21 : NO PRIMARY STABILITY -> DUE TO IMPROPER CEMENTING TECHNIQUE COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: LINE 21 : POSSIBLE -> THE REPORTED EVENT STATES THAT THE SURGEON WAS UNABLE TO POSITION THE CUP FOR 3 TIMES. SURGICAL REPORT WAS NOT PROVIDED. X-RAYS WHICH COULD HELP TO UNDERSTAND THE PATIENT'S CONDITION WERE NOT AVAILABLE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. THEREFORE, IT IS NOT POSSIBLE TO CONCLUDE ON THE FAILED ATTEMPTS TO FIX THE CUP DURING SURGERY. HOWEVER, THE DEVICE HISTORY RECORDS OF THE PRODUCTS SHOW THAT THE ARTICLES MET ALL THE REQUIREMENTS TO PERFORM AS INTENDED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, IT WAS NOT POSSIBLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS NOW BEEN FOUND THAT ALSO A REINFORCEMENT RING FROM ANOTHER COMPANY WAS USED, THEREFORE THIS CASE WAS RE-OPENED AND THE INVESTIGATION WAS PERFORMED AGAIN. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS NOT APPROVED BY ZIMMER. IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, THE PF STEM WAS CEMENTED AND THE HEAD WAS INSERTED ON THE STEM. HOWEVER, IMPLANTING THE CUP WAS DIFFICULT. THREE ATTEMPTS TO POSITION THE CEMENTED CUP INTO THE ACETABULUM WERE NOT SUCCESSFUL. SURGEON DECIDED TO REMOVE ALL THE DEVICES (CUP, HEAD, STEM). AT THE END OF THE SURGERY THE PATIENT HAD A RESECTION OF THE FEMUR HEAD. SURGERY WAS COMPLETED WITH "GIRDLESTONE PROCEDURE". THE PF STEM, THE BIOLOX DELTA HEAD AND TWO DURASUL LOW PROFILE CUPS WERE RECEIVED FOR THE INVESTIGATION. ALL OF THE IMPLANTS, EXCEPT THE BALL HEAD, WERE COVERED WITH BONE CEMENTS. THE FEMORAL HEAD SHOWED SIGNS OF USAGE. ANCHORING SURFACE OF THE HEAD APPEARED TO BE COVERED WITH METAL TRANSFER, WHICH SEEMED TO BE UNEXPECTEDLY MORE INTENSE FOR AN IMPLANT WITH NO IN-VIVO TIME. ARTICULATING SURFACE OF THE HEAD WAS OBSERVED TO BE INTACT. FEMORAL STEM WAS SHOWN TO HAVE SOME SCRATCHES ON THE NECK REGION. ONE OF THE CUPS RECEIVED WAS ATTACHED TO A REINFORCEMENT RING WITH HOOK BY THE HELP OF BONE CEMENT. THE OTHER CUP WAS ONLY COVERED WITH THE BONE CEMENT. BUT BOTH OF THE CUPS SEEMED TO BE FREE OF ANY DEFORMATION ON THE INNER SURFACE OF THEM. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.), DUE TO OFF-LABEL USE, COMBINATION WITH COMPETITOR PRODUCTS. COMPARISON TO INVESTIGATION RESULTS WHETHER IT IS POSSIBLE AND JUSTIFICATION: POSSIBLE, AS ZIMMER PRODUCT WAS USED WITH A REINFORCEMENT RING FROM A DIFFERENT MANUFACTURER. SURGICAL REPORT WAS NOT PROVIDED. X-RAYS WHICH COULD HELP TO UNDERSTAND PATIENT'S CONDITIONS WERE NOT AVAILABLE. PATIENT FACTORS THAT MIGHT AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY AND RELEVANT MEDICAL HISTORY WERE UNKNOWN. IT WAS UNKNOWN IN WHICH ORDER THE SURGEON TRIED THE IMPLANTATION OF THE 3 DIFFERENT CUPS. AMONG THE RECEIVED CUPS ONLY ONE OF THEM WAS ATTACHED TO THE REINFORCEMENT RING. IT WAS UNKNOWN WHETHER THE OTHER CUPS WERE USED WITH SAME RING OR NOT. HOWEVER, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE ROOT CAUSE IS OFF-LABEL USE DUE TO COMBINATION OF A ZIMMER PRODUCT WITH A REINFORCEMENT RING FROM A DIFFERENT MANUFACTURER. THE NEED FOR CORRECTIVE MEASURES 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 WAS REPORTED, THAT AN ATTEMPT WAS MADE TO IMPLANT A DURASUL LOW PROFILE CUP 50 / 36 ON (B)(6) 2015. THE SURGEON TRIED TO IMPLANT 3 CUPS IN DIFFERENT SIZES (DURASUL LOW PROFILE CUP 32 / 48, REF# 01.00324.048; LOT # 2794081; DURASUL LOW PROFILE CUP 50 /36; REF# 05.95001.051; LOT # 2752378; DURASUL LOW PROFILE CUP 52 / 36; REF# 05.95001.052; LOT# 2730813), BUT NONE OF THEM COULD BE FIXED ON THE BONE. THE SURGEON REMOVED ALL IMPLANTS AND FOLLOWED THE GIRDLESTONE PROCEDURE. THE SURGERY WAS DELAYED FOR 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440644 DURASUL LOW PROFILE CUP 50 / 36 DURASUL LOW PROFILE CUP KWA ZIMMER GMBH NA 2752378

    Patients

    Seq Age Sex Outcome Treatment
    1 Other