BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER HEAD 28 12/14

    MDR report key: 5382729 · Received January 21, 2016

    Report

    Report Number
    9613350-2016-00059
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 29, 2015
    Report Date
    June 29, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER FDA¿S DIRECTIVE, MEDWATCH REPORT HAS BEEN RESUBMITTED FOR REMOVING THREE ZEROS IN THE PREFIX OF MFR NUMBER(0009613350-2016-00059-1). ALL THE INFORMATION CAPTURED AS PER 0009613350-2016-00059-1 INCLUDING G4(DATE RECEIVED BY MANUFACTURER) EXCEPT B4. 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: PATIENT RECEIVED A BIOLOX HEAD ON FEBRUARY 8, 2010 AND WAS REVISED ON (B)(6) 2015 DUE TO PAIN AND WEAR. IMPLANTATION REPORT DATED (B)(6) 2010: A 61-YEAR-OLD MALE PATIENT UNDERWENT TO RIGHT THA DUE TO COMPLETE LOSS OF BONE CARTILAGE WITH MISSHAPEN FEMORAL HEAD AND BONE-ON-BONE HIP JOIN. DUAL MOBILITY CUP MANUFACTURED BY MEDACTA HAS BEEN IMPLANTED ON THE ACETABULAR SIDE. FITMORE STEM HAS BEEN IMPLANTED ON FEMORAL SIDE. REVISION REPORT DATED (B)(6) 2015: 67-YEAR-OLD MALE PATIENT HAS PAIN, HAS DEVELOPED A CYST IN THA REGION WITH PROBABLE LOOSENING OF THE ACETABULAR COMPONENT. INTRAOPERATIVE, THE SURGEON FOUND A THICK INFLAMMATORY MEMBRANE AROUND THE ACETABULAR COMPONENT. SEVERAL AMOUNT OF FIBROUS TISSUE FOUND IN THE PROXIMAL PART OF THE FEMORAL COMPONENT. HOWEVER, THE SURGEON FOUND THE FEMORAL COMPONENT TO BE VERY SOLID WITH WELL BONE INGROWTH. DEVICES ANALYSIS: ON THE ARTICULATING SURFACE OF THE BIOLOX HEAD A CLEAR LINE GENERATED BY METAL TRANSFER CAN BE CLEARLY OBSERVED. THIS LINE MOST PROBABLY OCCURRED DURING REVISION SURGERY AS THE SURGICAL REPORT DOES NOT STATE ANY CONTACT OF THE HEAD WITH THE CUP IN VIVO. ON THE INNER SURFACE THE HEAD SHOWS SEVERAL CONTACT LINES CHARACTERIZED BY METAL TRANSFER. THIS METAL TRANSFER UNDERLINES THAT THE HEAD WAS CORRECTLY PLACED ON STEM FOR THE TIME IN VIVO. IT CANNOT BE DETERMINED IF THE METAL TRANSFER ON THE INNER SURFACE IS SIMPLY DUE TO INSERTION/REMOVAL OF THE HEAD OR IS A CONSEQUENCE OF A WEAR PROCESS WITH THE STEM. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS NOT APPROVED BY ZIMMER BIOMET. ZIMMER HEAD AND STEM COMBINED WITH MEDACTA CUP AND LINER. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING TO DFMEA: LINE 24 : MAL-FUNCTION OF THA (WEAR, FRACTURE, DISLOCATION ETC.) DUE TO OFF LABEL USE, COMBINATION WITH COMPETITOR PRODUCTS . POSSIBLE: COMBINATION WITH COMPETITOR PRODUCT NOT ALLOWED. LINE 25 : LOSS OF CONNECTION DUE TO INADEQUATE ASSEMBLING PROCEDURE. POSSIBLE: COMBINATION WITH COMPETITOR PRODUCT NOT ALLOWED. CONCLUSION SUMMARY: ACCORDING TO SURGICAL REPORT OF IMPLANTATION, THE ZIMMER PRODUCT WERE COMBINED WITH COMPETITOR PRODUCT. THE WEAR PROCESS OBSERVED BETWEEN THE HEAD AND THE STEM COULD HAVE BEEN CAUSED BY AN INCOMPATIBILITY OF THE HEAD WITH THE INSERT/CUP SYSTEM. IN FACT, AS REPORTED IN THE SURGICAL REPORT A LOOSENING OF THE ACETABULAR COMPONENT HAS BEEN NOTICED. THEREFORE, THE ROOT CAUSE IS OFF-LABEL USE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO PAIN AND WEAR.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. THIS IS A SPLIT CASE WITH ZIMMER (B)(4). 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX DELTA CER HEAD 28 12/14 ON THE RIGHT SIDE ON (B)(6) 2010, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PAIN AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41720 BIOLOX DELTA CER HEAD 28 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R