BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14

    MDR report key: 7755537 · Received August 7, 2018

    Report

    Report Number
    0009613350-2018-00691
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    June 16, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071535
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: IF FOLLOW-UP, WHAT TYPE. CORRECTION: DATE OF REPORT, EVENT, CONCOMITANT MEDICAL PRODUCTS, DATE REC¿D BY MFR, PMA/510K, DEVICE EVALUATED BY MFR. DHR-REVIEW: REF:00-8775-028-01 ; LOT:2711239, YIELD:105, DELIVERED:104, SCRAPPED:01, REASON FOR SCRAPPING: DAMAGE. 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: FRACTURED CERAMIC HEAD. EVENT DESCRIPTION: IT WAS REPORTED THAT THE BIOLOX HEAD FRACTURED UPON TRYING TO IMPACT, AFTER THE HEAD WAS SET INTO THE DUAL MOBILITY LINER. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: VISUAL EXAMINATION: THE FRACTURED BIOLOX HEAD HAS BEEN RETURNED FOR AN INVESTIGATION ASSEMBLED WITH THE DUAL MOBILITY LINER. ONE PIECE AROUND THE TAPER OF THE HEAD HAS FRACTURED OFF. THIS BROKEN OFF PIECE HAS NOT BEEN RETURNED FOR AN INVESTIGATION. MOREOVER, THERE IS A SIGN OF METAL TRANSFER AT THE RIM OF THE HEAD, BUT NO SIGNS WITHIN THE REMAINING PART TAPER. THIS INDICATES, THAT THE BIOLOX HEAD MUST HAVE FRACTURED BEFORE BEING COMPLETELY IMPACTED ON THE STEM TAPER. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK FOR THE BIOLOX HEAD AND ACTIVE ARTICULATION LINER WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: IMPLANT BREAKAGE DUE TO INSUFFICIENT FATIGUE STRENGTH NOT POSSIBLE. A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. IMPLANT BREAKAGE DUE TO INSUFFICIENT MATERIAL THICKNESS LEADING TO IMPLANT BREAKAGE NOT POSSIBLE. A SYSTEMATIC ISSUE WITH DESIGN AND/OR MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. IMPLANT BREAKAGE, NERVE INJURIES, VASCULAR INJURIES DUE TO DESIGN SPECIFICATION NOT MET NOT POSSIBLE THE REVIEW OF THE DEVICE HISTORY RECORDS CONFIRM THAT THE IMPLANT MET ALL SPECIFICATIONS. IMPLANT BREAKAGE, ABRASIVE WEAR, DISSOCIATION, NERVE INJURIES, VASCULAR INJURIES DUE TO DESIGN SPECIFICATION NOT MET (E.G. HEAD DOES NOT PROVIDE FEEDBACK DURING ASSEMBLY ONTO STEM TAPER). NOT POSSIBLE. THE REVIEW OF THE DEVICE HISTORY RECORDS CONFIRM THAT THE IMPLANT MET ALL SPECIFICATIONS. IMPLANT BREAKAGE, IMPLANT SURFACE DAMAGE, NERVE INJURIES, VASCULAR INJURIES DUE TO EXCESSIVE IMPACTION FORCE WHEN ASSEMBLING HEAD ON STEM TAPER. POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. 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, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. AS THERE ARE ONLY METAL TRANSFER LINES AT THE RIM OF THE HEAD, AN OFF-AXIS/INAPPROPRIATE ASSEMBLY CANNOT BE EXCLUDED. INCREASED WEAR, DAMAGED IMPLANT DUE TO INADEQUATE HANDLING OF THE MEDICAL DEVICE IN THE OR LEADING TO DAMAGED DEVICE. POSSIBLE, AS IT CANNOT BE EXCLUDED BASED ON THE AVAILABLE INFORMATION. AS THERE ARE ONLY METAL TRANSFER LINES AT THE RIM OF THE HEAD, AN INADEQUATE HANDLING OF THE DEVICE 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. POSSIBLE, AS IT IS UNKNOWN WHICH STEM WAS IMPLANTED. HOWEVER, THE HEAD AND LINER ARE COMPATIBLE. CONCLUSION SUMMARY: THE FRACTURED BIOLOX HEAD HAS BEEN RETURNED FOR AN INVESTIGATION ASSEMBLED WITH THE DUAL MOBILITY LINER. THEREFORE THE COMPLAINT COULD BE CONFIRMED. THE REVIEW OF THE DEVICE HISTORY RECORDS AND RAW MATERIAL CERTIFICATE INDICATES THAT THE HEAD MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE VISUAL EXAMINATION SHOWED, THAT THE BIOLOX HEAD HAS NOT YET BEEN ASSEMBLED COMPLETELY WITH THE STEM TAPER, AS THERE ARE NO METAL TRANSFER LINE IN THE REMAINING PART OF THE TAPER OF THE BIOLOX HEAD. HOWEVER, THE FRACTURED OFF PIECE HAS NOT BEEN RETURNED. IT MIGHT BE POSSIBLE, THAT THE BIOLOX HEAD HAS BEEN IMPACTED OFF-AXIS, LEADING TO THE FRACTURE OF THE HEAD. THE METAL TRANSFER LINE AT THE RIM OF THE BIOLOX HEAD, OPPOSITE TO THE FRACTURE SURFACE, SUPPORTS THIS POSSIBILITY. AFTER THE PIECE HAS FRACTURED OFF DUE TO AN OFF-AXIS IMPACTION, THIS PART OF THE RIM WOULD BE IN CONTACT WITH THE STEM. HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE FOR THE FRACTURE OF THE BIOLOX HEAD COULD NOT 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).

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS ACCORDING: ITEM: ACT ARTIC E1 HIP BRG 28X42MM S48 DIA28, CATALOG #: EP-200148, LOT #: 944010. THE MANUFACTURER DID NOT RECEIVE THE DEVICE YET, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. 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 (B)(6) 2018 TO THE APPROPRIATE REPRESENTATIVES. 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). 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 DURING THE SURGERY THE BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14 FRACTURED WHILE TRYING TO IMPACT AFTER THE HEAD WAS SET INTO THE DUAL MOBILITY LINER. NOTE: THE DEVICE WAS NOT IMPLANTED AS IT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600752 BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2711239

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR