BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, KK/36

    MDR report key: 7333438 · Received March 13, 2018

    Report

    Report Number
    0009613350-2018-00346
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 13, 2018
    Report Date
    August 24, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY INVESTIGATION RESULT. DHR REVIEW: THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION. EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT WOULD LEAN FOR WARD AND HIP WOULD START TO DISLOCATE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION SURGERY AROUND 7 MONTHS POST IMPLANTATION. 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: FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO INADEQUATE TAPER CONNECTION DESIGN LEADS TO DISSOCIATION OF THE CERAMIC HEAD (TAPER CONNECTION NOT ABLE TO RESIST THE IMPACTION FORCE) NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO INADEQUATE HEAD DESIGN LEADS TO IMPINGEMENT; LIMITED RANGE OF MOTION NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, DISSOCIATION, ASEPTIC LOOSENING OF STEM, OSTEOLYSIS DUE TO INSUFFICIENT CONNECTION STRENGTH MICROMOTION LEADING TO WEAR IN TAPER CONNECTION BETWEEN STEM AND HEAD POSSIBLE, NO DEVICE WAS RECEIVED FOR INVESTIGATION, THE CONDITION OF THE DEVICE IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. POSTOPERATIVE TISSUE REACTION, METALOSIS, DISLOCATION, ASEPTIC LOOSENING OF STEM, OSTEOLYSIS DUE TO PE, CERAMIC OR METAL PARTICLE RELEASE FROM ARTICULATION (HEAD AND INLAY) OR TAPER (HEAD AND STEM) CONNECTION DUE TO WEAR POSSIBLE, NO DEVICE WAS RECEIVED FOR INVESTIGATION, THE CONDITION OF THE DEVICE IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. POSTOPERATIVE TISSUE REACTION, DISLOCATION, ASEPTIC LOOSENING OF STEM, INCREASED WEAR, OSTEOLYSIS DUE TO INCREASED FRICTION FOR CERAMIC-ON-POLY OR CERAMIC-ON-CERAMIC BEARING LEADING TO LOOSENING OF COMPONENTS OR INCREASED WEAR POSSIBLE, NO DEVICE WAS RECEIVED FOR INVESTIGATION, THE CONDITION OF THE DEVICE IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, DISSOCIATION, ABRASIVE WEAR, LIMITED ROM, IMPINGEMENT DUE TO INADEQUATE HEAD AND/OR ADAPTER DESIGN LEADS TO IMPINGEMENT (COMPONENT TO BONE) WITH STEM NOT POSSIBLE A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO IMPINGEMENT (COMPONENT TO BONE, COMPONENT TO COMPONENT, COMPONENT TO SOFT TISSUE) DUE TO MALPOSITION OF COMPONENTS (STEM, HEAD, CUP) => POSSIBLE, NO X-RAY AND NO SURGICAL REPORT WAS REVIEWED FOR ASSESSMENT. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. 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) NOT POSSIBLE COMBINATION IS ALLOWED/APPROVED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, IMPLANT BREAKAGE, CORROSION, METALOSIS, DISLOCATION, SUBLUXATION, ABRASIVE WEAR DUE TO HEAD IS IMPLANTED ON A DAMAGED STEM TAPER; USAGE OF A WET AND/OR UNCLEAN STEM AND/OR HEAD TAPER (PARTICLES BETWEEN STEM TAPER AND BALL HEAD TAPER) => POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR ASSESSMENT, IT CANNOT BE VERIFIED IF THE TAPER WAS CLEANED AND DRIED INTRAOPERATIVELY; IT ALSO CANNOT BE EVALUATED IF THE STEM TAPER WAS INTACT, SINCE THE DEVICE IS NOT AT HAND FOR INVESTIGATION. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, FRETTING CORROSION, DISLOCATION, DISSOCIATION, IMPLANT FRACTURE, SOFT TISSUE IMPINGEMENT DUE TO INAPPROPRIATE ASSEMBLING OF HEAD WITH STEM (E.G. INSUFFICIENT IMPACTION FORCE AND/ OR OFF AXIS IMPACTION, TORQUE ON HEAD) POSSIBLE, NO SURGICAL REPORT OF IMPLANTATION WAS RECEIVED FOR ASSESSMENT, IT CANNOT BE VERIFIED IF APPROPRIATED ASSEMBLING OF HEAD WITH STEM WAS PERFORMED INTRAOPERATIVELY. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY, IMPINGEMENT, LIMITED RANGE OF MOTION DUE TO SOFT TISSUE LAXITY POSSIBLE, NO MEDICAL REPORTS, NEITHER SURGICAL REPORT WERE RECEIVED FOR REVIEW. THEREFORE THE CONDITION OF PATIENT'S SOFT TISSUES IS UNKNOWN. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, FRETTING CORROSION, DISLOCATION, DISSOCIATION DUE TO EXPLANTED CERAMIC HEAD IS REUSED WITH THE SAME OR NEW FEMORAL STEM NOT POSSIBLE IT IS VERY UNLIKELY THAT A REUSED DEVICE WAS USED. NO INFORMATION WHICH COULD POINT ON THAT WAS RECEIVED. 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 OF COMPONENTS USED; COMBINATION WITH COMPETITOR PRODUCTS NOT POSSIBLE COMBINATION IS ALLOWED/APPROVED. DISLOCATION, SUBLUXATION, ASEPTIC LOOSENING DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT => POSSIBLE, NO DEVICE HAS BEEN RETURNED FOR INVESTIGATION. CORRECT PRODUCT INFORMATION CANNOT BE VERIFIED. THEREFORE, THIS POINT CANNOT BE EXCLUDED. FAILURE OF CONNECTION BETWEEN STEM AND BALL HEAD, ABRASIVE WEAR, DISLOCATION, SUBLUXATION, FRACTURE OF HEAD DUE TO LASER MARKING NOT READABLE IN NORMAL LIGHTING CONDITIONS LEADS TO USE OF WRONG HEAD POSSIBLE, NO DEVICE HAS BEEN RETURNED FOR INVESTIGATION. CORRECT PRODUCT INFORMATION CANNOT BE VERIFIED. THEREFORE, THIS POINT CANNOT BE EXCLUDED IMPLANT BREAKAGE, DISLOCATION DUE TO INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON POSTOPERATIVE ACTIVITIES AND LIMITS. POSSIBLE, NO MEDICAL REPORTS, NEITHER REHABILITATION REPORT WAS RECEIVED FOR REVIEW. THEREFORE, THIS POINT CANNOT BE EXCLUDED CONCLUSION: IT WAS REPORTED THAT A PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT SUBSEQUENTLY A REVISION SURGERY. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANTS WERE RECEIVED; THEREFORE 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.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 PRODUCT(S): - BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14, REF# 00-8775-036-01, LOT#2880096. - ALLOFIT ALLOCLASSIC SHL 56/KK, REF#4247, LOT# 2889770. - AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14, REF# 0106010003, LOT#: 2841592. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00347. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THE ACTUAL DEVICE REPORTED, IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E DURASUL ALPHA EINSATZ NEUTRAL Ø GG/32 / DURASUL LINERS / K993259 ) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION SURGERY DUE TO DISLOCATION AFTER APPROXIMATELY 7 MONTHS IN VIVO. THE SURGEON CHOOSE TO REPLACE THE HEAD WITH BIOBALL IMPLANTS TO INCREASE OFFSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177421 DURASUL, ALPHA INSERT, KK/36 N/A JDI ZIMMER GMBH N/A 2884269

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R