BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULOX, HEAD, M, 32/0, TAPER 12/14

    MDR report key: 6867916 · Received September 15, 2017

    Report

    Report Number
    0009613350-2017-01224
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    March 24, 2017
    Report Date
    February 13, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK042249
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS FOR ZIMMER SPECIALISTS TO PERFORM AN IN-DEPTH ANALYSIS IT IS REQUIRED TO HAVE ALL NECESSARY INFORMATION AT HAND, IT WAS THEREFOR TRIED SEVERAL TIMES TO RECEIVE MORE INFORMATION FOR THIS CASE. THE REQUESTED ADDITIONAL INFORMATION IS CURRENTLY NOT AVAILABLE. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: REVISION DUE TO DISLOCATION. DEVICE HISTORY RECORDS (DHR): HEAD NUMBER 16@2255502 WAS PART OF ORDER #(B)(4) WHICH WAS DISTRIBUTED OVER THE BELOW ZIMMER BIOMET LOTS: 2864811, 2862439, 2862441, 2862442, 2868481, 2862445, 2862443, 2864812, 2862446. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: IT IS REPORTED THAT ON (B)(6) 2017 PATIENT UNDERWENT REVISION DUE TO DISLOCATION AND PAIN. ALL PRODUCTS WERE EXCHANGED. PREVIOUSLY, PATIENT WAS IMPLANTED WITH A ZIMMER BIOMET, WINTERTHUR HIP IMPLANT ON (B)(6) 2008 AND HAD UNDERGONE FIRST REVISION ON (B)(6) 2017 TO EXCHANGE FEMORAL STEM DUE TO LOOSENING. THAT COMPLAINT IS CAPTURED UNDER (B)(4). REVIEW OF RECEIVED DATA - ATTORNEY LETTER TO THE PATIENT DATED (B)(6) 2017 INDICATES THAT THE REVISION SURGERY REPORTS WERE REVIEWED. IN THE FIRST REVISION REPORT IT WAS SEEN THAT THE ACETABULUM COMPONENT WAS CHECKED AND FOUND TO BE GOOD, WHICH WAS INTACT AND WAS FIRMLY IN. IN THE SECOND REVISION REPORT IT WAS SHOWN THAT THE WEAR OF THE ACETABULUM DID NOT LEAD TO THE DISLOCATIONS THAT HAD BEEN DIAGNOSED, BUT DISLOCATION WAS ONLY POSSIBLE WITH EXTERNAL ROTATION AND HYPEREXTENSION OF THE LEG. PATIENT LETTER TO THE ATTORNEY DATED (B)(6) 2017 AND (B)(6) 2017 INDICATE THAT THE PATIENT THINKS THE ACETABULAR COMPONENT SHOULD HAVE BEEN REVISED ALONG WITH THE STEM AND HEAD DURING THE FIRST REVISION SURGERY. IT IS SAID THAT PREVIOUS STEM WAS LOOSENED AND INSTEAD A LONGER STEM WAS IMPLANTED. MOREOVER, IT IS TOLD THAT THE PATIENT HAD 2 DISLOCATION EVENTS OF THE HIP IN 10 DAYS AFTER THE REVISION SURGERY ON MAR 24. IT IS INDICATED THAT THE PATIENT IS AN EXPERIENCED NURSE SO WRONG MOVEMENTS WERE AVOIDED. ATTORNEY LETTER TO ZIMMER BIOMET DATED AUG 21, 2017 DOES NOT PROVIDE ANY VALUABLE INFORMATION. DEVICES ANALYSIS - VISUAL EXAMINATION: SULOX CERAMIC HEAD 32MM M SIZE, METALLIC SHELL AND PE LINER WERE RECEIVED FOR THE INVESTIGATION. IT HAS BEEN NOTICED THAT THE METALLIC SHELL AND INLAY BELONG TO SMITH & NEPHEW, WHILE THE CERAMIC HEAD BELONGS TO ZIMMER BIOMET WINTERTHUR. METALLIC SHELL IS SEEN TO HAVE BONE ATTACHMENTS ON THE OUTER SURFACE. PE INSERT HAS SCRATCHES ON THE FRONT SURFACE AND A HOLE ON THE ARTICULATING SURFACE DUE TO EXTRACTION FORCES APPLIED. THE SULOX HEAD APPEARS WITHOUT SIGNIFICANT IMPERFECTIONS AND DETERIORATIONS. THE ARTICULATING SURFACE OF THE HEAD HAS A COUPLE OF SLIGHT METAL TRANSFER LINES, WHICH ARE SUPPOSED TO HAPPEN DURING REMOVAL BY SCRATCHING. THE CONICAL BORE SURFACE OF THE HEAD PRESENTS SIGNIFICANT METAL TRANSFER. IN THE CASE OF A SYMMETRICAL TAPER FIT SITUATION BETWEEN THE CERAMIC BALL HEAD AND THE METALLIC STEM TAPER, THIN CONCENTRIC LINES (PRIMARY METAL TRANSFER) OVER THE WHOLE CIRCUMFERENCE OF THE TOP TAPER ZONE ARE EXPECTED. THESE PRIMARY METAL TRANSFER PATTERNS CAN BE FOUND WITH VARYING INTENSITY ON THE CONICAL BORE SURFACE. MOREOVER, ON THE LOWER AND MIDDLE TAPER ZONE METAL TRANSFER LOCALIZED MOSTLY ON A PARTICULAR SIDE IS VISIBLE. THOSE FEATURES ARE ASSUMED TO BE INDICATIONS OF A MISALIGNMENT OF HEAD ON THE STEM DURING/POST SURGERY. REVIEW OF PRODUCT DOCUMENTATION - ZIMMER BIOMET IMPLANT (SULOX HEAD) WAS COMBINED WITH COMPETITOR'S (SMITH & NEPHEW) PRODUCTS, WHICH IS NOT ALLOWED BY ZIMMER BIOMET. IT IS STATED IN D011500200 - INSTRUCTION LEAFLET FOR ENDOPROSTHESES, WHICH IS INCLUDED IN THE SULOX PRODUCT PACKAGE, ON PAGE 2 THAT "ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. TO DETERMINE WHETHER THESE DEVICES HAVE BEEN AUTHORIZED FOR USE IN A PROPOSED COMBINATION, PLEASE CONTACT YOUR ZIMMER SALES REPRESENTATIVE OR VISIT THE ZIMMER WEBSITE: WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM." ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING DFMEA: - MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.) DUE TO WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET => POSSIBLE: THE STEM IMPLANTED WITH THE CERAMIC HEAD IS UNKNOWN. NO X-RAYS WERE RECEIVED. THEREFORE CORRECT SIZES CANNOT BE CONFIRMED. - INCREASED CHEMICAL, GALVANIC OR CREVICE CORROSION AND / OR FRETTING OF MATERIAL, METAL ION RELEASE DUE TO NOT ALLOWED/ WRONG COMBINATION OF ZIMMER PRODUCTS => POSSIBLE: ZIMMER BIOMET IMPLANT (SULOX HEAD) WAS COMBINED WITH COMPETITOR'S (SMITH & NEPHEW) PRODUCTS, WHICH IS NOT ALLOWED BY ZIMMER BIOMET. CONCLUSION SUMMARY: PATIENT UNDERWENT A REVISION SURGERY OF THE CERAMIC HEAD AND ACETABULAR COMPONENTS DUE TO DISLOCATION ON (B)(6) 2017. PREVIOUSLY, PATIENT HAD UNDERGONE A REVISON SURGERY OF THE FEMORAL HEAD AND STEM ON (B)(6) 2017. DURING THE FIRST REVISION SURGERY, SMITH & NEPHEW FEMORAL HEAD AND STEM WERE REVISED WITH ZIMMER BIOMET HEAD AND UNKNOWN STEM. THUS, THE SURGEON COMBINED THE SMITH & NEPHEW ACETABULAR CUP AND LINER WITH THE ZIMMER BIOMET HEAD. THIS COMBINATION IS NOT ALLOWED BY ZIMMET BIOMET. POSSIBLE REASONS FOR THE DISLOCATION EVENT INCLUDE THE WRONG HEAD OFFSET/DIAMETER SELECTION, MALPOSITIONING OF THE IMPLANTS AND NOT ALLOWED COMBIANTION OF ZIMMER BIOMET PRODUCTS. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. ROOT CAUSE IS INAPPROPRIATE COMBINATION OF ZIMMER BIOMET PRODUCTS. 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 · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A SULOX, HEAD, M, 32/0, TAPER 12/14 ON AN UNKNOWN SIDE ON (B)(6) 2017 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO DISLOCATION AND PAIN.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS PENDING. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. CONCLUSION SUMMARY: PATIENT UNDERWENT A REVISION SURGERY OF THE CERAMIC HEAD AND ACETABULAR COMPONENTS DUE TO DISLOCATION ON (B)(6) 2017. PREVIOUSLY, PATIENT HAD UNDERGONE A REVISION SURGERY OF THE HEAD AND STEM ON (B)(6) 2017. DURING THE FIRST REVISION SURGERY, SMITH & NEPHEW FEMORAL HEAD AND STEM WERE REVISED WITH ZIMMER BIOMET HEAD AND UNKNOWN STEM. THUS, THE SURGEON COMBINED THE SMITH & NEPHEW ACETABULAR CUP AND LINER WITH THE ZIMMER BIOMET HEAD. THIS COMBINATION IS NOT ALLOWED BY ZIMMER BIOMET. MOREOVER, THE STEM WHICH WAS IMPLANTED DURING THE SURGERY ON (B)(6) 2017 IS ALSO UNKNOWN. THEREFORE, WE CANNOT EXCLUDE A POSSIBLE RISK OF COMBINATION OF SULOX HEAD WITH A COMPETITOR STEM. IT IS STATED IN INSTRUCTION LEAFLET FOR ENDOPROSTHESES, WHICH IS INCLUDED IN THE SULOX CERAMIC HEAD PRODUCT PACKAGE, ON PAGE 2 THAT "ONLY AUTHORIZED COMBINATIONS SHOULD BE USED. TO DETERMINE WHETHER THESE DEVICES HAVE BEEN AUTHORIZED FOR USE IN A PROPOSED COMBINATION, PLEASE CONTACT YOUR ZIMMER SALES REPRESENTATIVE OR VISIT THE ZIMMER WEBSITE: WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM." POSSIBLE REASONS FOR THE DISLOCATION EVENT INCLUDE THE WRONG HEAD OFFSET/DIAMETER SELECTION, MALPOSITIONING OF THE IMPLANTS AND NOT ALLOWED COMBINATION OF ZIMMER BIOMET PRODUCTS. NEITHER X-RAYS, SURGICAL REPORTS NOR THE PRODUCT IDENTIFICATION OF THE STEM IMPLANTED ON (B)(6) 2017 WERE AVAILABLE FOR THE INVESTIGATION; THEREFORE THE STATEMENT OF THE FACTS IN THE RECEIVED LETTERS CANNOT BE CONFIRMED AND IT IS NOT POSSIBLE TO COMMENT FURTHER ON MOST OF THE POSSIBLE ROOT CAUSES. HOWEVER, AS THE ZIMMER CERAMIC HEAD WAS COMBINED WITH SMITH & NEPHEW INSERT/CUP, THE MOST POSSIBLE ROOT CAUSE IS CONSIDERED AS OFF LABEL USE - INAPPROPRIATE COMBINATION OF PRODUCTS. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A CERAMIC HEAD ON AN UNKNOWN SIDE ON (B)(6) 2017 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO DISLOCATION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651035 SULOX, HEAD, M, 32/0, TAPER 12/14 UNKNOWN CERAMIC HEAD LZO ZIMMER GMBH N/A 2864812

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R