BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14

    MDR report key: 7595485 · Received June 13, 2018

    Report

    Report Number
    0009613350-2018-00614
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 4, 2018
    Report Date
    November 27, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION. EVENT SUMMARY: THE PATIENT HAD THE IMPLANTATION SURGERY ON (B)(6) 2018 SUBSEQUENTLY, THE PATIENT HAD A FALL AND THE X-RAYS TAKEN AFTER CONFIRMED THAT THE HEAD DISLOCATED FROM THE CUP. THE REVISION SURGERY WAS PERFORMED (B)(6) 2018 REVIEW OF RECEIVED DATA. X-RAYS ASSESSMENT REVIEWED BY HCP: (B)(6) 2018AP VIEW X-RAY SHOWS ANATOMIC ALIGNMENT OF RIGHT HIP NON-CEMENTED ARTHROPLASTY COMPONENTS. (B)(6) 2018 AP VIEW X-RAY SHOWS LATERAL DISPLACEMENT OF THE ACETABULAR COMPONENT OUT OF THE ACETABULUM. THE PROSTHETIC FEMORAL HEAD IS SEATED WITHIN THE ACETABULUM. UNDATED AP VIEW SHOWS BOTH THE ACETABULAR COMPONENT AND FEMORAL COMPONENT (WHICH REMAIN ALIGNED WITH EACH OTHER) DISPLACED SUPEROLATERALLY FROM THE NATIVE ACETABULUM. PICTURES OF THE BIOLOX HEAD AFTER THE REVISION SURGERY ARE RECEIVED. METALLIC TRANSFER IS OBSERVED AT THE RIM AND ON THE INNER TAPER SURFACE OF THE HEAD. CONCENTRIC LINES AT THE TOP TAPER ZONE INDICATES THE PRIMARY METALLIC TRANSFER OCCURRED DURING SEATING THE HEAD ON THE STEM TAPER. HOWEVER, THEY CANNOT BE EVALUATED AS THERE IS ONLY ONE PICTURE SHOWING THE ZONE BLURRY. AT THE LOWER TAPER AREA METAL TRANSFER DUE TO REMOVAL OF THE HEAD FROM THE STEM IS OBSERVED. ON THE ARTICULATING SURFACE OF THE HEAD SLIGHT METAL TRANSFER IS VISIBLE IN THE FORM OF SCRATCHES, WHICH MOST PROBABLY HAPPENED AFTER THE DISLOCATION OF THE HIP. NO ABNORMALITY REGARDING THE POSITIONING OF THE HEAD IS NOTICED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: 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, IT IS NOT REPORTED, HOWEVER 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 AND OR MATERIAL PROPERTIES 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, X-RAY BEFORE REVISION SURGERY. SHOWS THAT THE CUP HAS A QUITE LOW INCLINATION ANGLE, WHICH COULD HAVE LED TO DISLOCATION OF HEAD. 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 CORRECT COMPONENTS WERE SELECTED. 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, CANT BE CONFIRMED, THEREFORE 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, CANT BE CONFIRMED, THEREFORE CANNOT BE EXCLUDED. DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY, IMPINGEMENT, LIMITED RANGE OF MOTION DUE TO SOFT TISSUE LAXITY POSSIBLE, IT IS NOT REPORTED, HOWEVER CANNOT BE EXCLUDED. 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 PRODUCT COMBINATION WAS ALLOWED. DISLOCATION, SUBLUXATION, ASEPTIC LOOSENING DUE TO INAPPROPRIATE INFORMATION ON PACKAGING LABEL OR NOT LEGIBLE PACKAGING LABEL LEADS TO INCORRECT USE OF IMPLANT NOT POSSIBLE IFU (CHAPTERS: INDICATIONS AND WARNINGS) PROVIDES THE NECESSARY AND APPROPRIATE INFORMATION. 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 NOT POSSIBLE DHR OF THE PRODUCT SHOWS RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. IMPLANT BREAKAGE, DISLOCATION DUE TO INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON POSTOPERATIVE ACTIVITIES AND LIMITS. POSSIBLE, CANT BE CONFIRMED, THEREFORE CANNOT BE EXCLUDED. CONCLUSION SUMMARY PATIENT UNDERWENT REVISION SURGERY AFTER APPROX. 1.5 MONTHS IN-VIVO TIME DUE TO DISLOCATION. SURGICAL NOTES AND THE PRODUCT WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. RAW MATERIAL CERTIFICATE CONFIRMS THAT THE DEVICE WAS MANUFACTURED ACCORDING TO THE MATERIAL SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PRODUCT DID NOT IDENTIFY ANY DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. NEVERTHELESS, POSSIBLE REASONS LEADING TO THE DISLOCATION EVENT INCLUDE PE, CERAMIC OR METAL PARTICLE RELEASE FROM ARTICULATION (HEAD AND INLAY) OR TAPER (HEAD AND STEM) CONNECTION DUE TO WEAR, IMPINGEMENT (COMPONENT TO BONE, COMPONENT TO COMPONENT, COMPONENT TO SOFT TISSUE) DUE TO MALPOSITION OF COMPONENTS (STEM, HEAD, CUP), IMPLANTATION 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), INAPPROPRIATE ASSEMBLING OF HEAD WITH STEM (E.G. INSUFFICIENT IMPACTION FORCE AND/ OR OFF AXIS IMPACTION, TORQUE ON HEAD), SOFT TISSUE LAXITY AND INAPPROPRIATE ADVICE BY SURGEON TO INFORM PATIENT ON POSTOPERATIVE ACTIVITIES AND LIMITS. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. 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).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: ITEM NUMBER: 00771300900, ITEM NAME: MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 9, LOT # 63802366; ITEM NUMBER: 00784802200, ITEM NAME: MODULAR NECK B 12/14 NECK TAPER USE WITH +0 HEADS ONLY, LOT # 63822967; ITEM NUMBER: 110010456, ITEM NAME: RINGLOC BIPOLAR 28X49MM, LOT # 384870. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION BUT IT IS MENTIONED BY COMPLAINANT THAT IT WILL BE PROVIDED. X-RAYS AND PICTURES WERE PROVIDED 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. 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. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC (B)(4). (0001825034-2018-03729). ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A THA AND WAS REVISED AFTER 2 MONTHS DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437553 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2927572

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R