BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14

    MDR report key: 7398594 · Received April 5, 2018

    Report

    Report Number
    0009613350-2018-00419
    Event Type
    Injury
    Date Received
    April 5, 2018
    Report Date
    September 17, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND IDENTIFIED. EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A BIOLOX DELTA HEAD ON RIGHT HIP SIDE ON SEPTEMBER 12, 2017. THE PATIENT REPORTED THAT EVERYTHING WAS PERFECT WITH THE HIP. SUBSEQUENTLY THE PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON FEBRUARY 12, 2018. TWO DAYS AFTER THE LEFT HIP ARTHROPLASTY, THE RIGHT HIP WAS REPORTED TO "COMPLETELY SHUT DOWN", SHOWING PAIN, LIMITED RANGE OF MOTION , A LEG LENGTH DIFFERENCE AND INSTABILITY. THERE IS NO COMPLICATIONS WITH THE LEFT HIP. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING SAP RMW FOR THE BIOLOX CERAMIC HEAD: - POSTOPERATIVE TISSUE REACTION ON BURRS / SHARP EDGES DUE TO INSUFFICIENT MANUFACTURING PROCESS. NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT - DISLOCATION, SUBLUXATION, LEG LENGTH DISCREPANCY, ASEPTIC LOOSENING OF COMPONENTS DUE TO SELECTION OF WRONG COMPONENTS (E.G. WRONG SIZE OF HEAD DIAMETER AND/OR OFFSET) => POSSIBLE, AS NO X-RAYS HAVE BEEN RECEIVED, IT CANNOT BE DETERMINED WHETHER THE RIGHT COMPONENTS FOR THE PATIENT HAVE BEEN CHOSEN. HOWEVER, THE IMPLANTS WERE FOUND TO BE COMPATIBLE. - DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY, IMPINGEMENT, LIMITED RANGE OF MOTION DUE TO SOFT TISSUE LAXITY => POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. - FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION, FRACTURE OF HEAD, LEG LENGTH DISCREPANCY DUE TO OFF LABEL USE; WRONG COMBINATION CONCLUSION: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A BIOLOX DELTA HEAD ON RIGHT HIP SIDE ON SEPTEMBER 12, 2017. THE PATIENT REPORTED THAT EVERYTHING WAS PERFECT WITH THE HIP. SUBSEQUENTLY THE PATIENT UNDERWENT LEFT HIP ARTHROPLASTY ON FEBRUARY 12, 2018. TWO DAYS AFTER THE LEFT HIP ARTHROPLASTY, THE RIGHT HIP WAS REPORTED TO "COMPLETELY SHUT DOWN", SHOWING PAIN, LIMITED RANGE OF MOTION , A LEG LENGTH DIFFERENCE AND INSTABILITY. THERE IS NO COMPLICATIONS WITH THE LEFT HIP. THE MANUFACTURING RECORDS CONFIRM THAT THE DEVICES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. AS NO X-RAYS HAVE BEEN RECEIVED, THE IMPLANT POSITION OF THE LEFT AND RIGHT HIP COULD NOT BE INVESTIGATED. DUE TO THE LIMITED AMOUNT OF INFORMATION, THE CONDITION OF THE COMPONENTS IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. MOREOVER, PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE AND CAN HAVE NUMEROUS CAUSES. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. 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

    CONCOMITANT MEDICAL PRODUCTS: ITEM: ALLOCLASSIC SL STEM 6 12/14, CATALOG #: 2846, LOT #: 2864130; ITEM: SHELL WITH CLUSTER HOLES POROUS 62 MM, CATALOG #: 00875706201 , LOT #: 63565136; ITEM: LINER NEUTRAL 40 MM I.D. SIZE NN FOR USE WITH 62 MM, CATALOG #: 00875101540, LOT #: 63084154. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON APRIL 03, 2018 TO THE APPROPRIATE REPRESENTATIVES. EXACT EVENT DATE. SURGICAL REPORTS. ALL AVAILABLE X-RAYS DURING TIME IN- VIVO WITH PRINTED DATE. ALL AVAILABLE INTRAOPERATIVE PICTURES. WERE THERE ANY CONTRIBUTING CONDITIONS RELATED TO THE LEG LENGTH DISCREPANCY? (EX: TRAUMA, ILLNESS, PREVIOUS SURGERY, RELATED NON-COMPLIANCE, PATIENT ANATOMY). WAS THE SURGICAL TECHNIQUE FOR THE PRODUCT UTILIZED? 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 REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350 - 2018 - 00422. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(6) REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 0/-3.5, TAPER 12/14. SUBSEQUENTLY PATIENT EXPERIENCED PAIN, LIMITED RANGE OF MOTION, INSTABILITY AND LEG LENGTH DISCREPANCY AND IS MONITORED. NOTE: EXPLANTATION DATE IS EMPTY AS THE DEVICE REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243088 BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2867135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other