BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14

    MDR report key: 7755542 · Received August 7, 2018

    Report

    Report Number
    0009613350-2018-00701
    Event Type
    Injury
    Date Received
    August 7, 2018
    Report Date
    November 20, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: REF#: 00-8775-036-04 LOT#: 2791392. YIELD: (B)(4). DELIVERED: (B)(4). 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: POLYETHYLENE WEAR. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO LISTHESIS III PROXIMAL FEMORAL STEM, EXCESSIVE ANTEVERSION OF CUP AND POLYETHYLENE WEAR. THE XPE LINER WAS REPLACED, BUT IT IS UNCLEAR WHETHER THE BIOLOX HEAD WAS ALSO REVISED. REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: AS THE STEM AND THE CUP IN THE REVISED CONSTRUCT IS UNKNOWN, ONLY THE COMPATIBILITY OF HEAD AND LINER WAS CHECKED. THE COMBINATION OF THE HEAD AND LINER WAS APPROVED BY ZIMMER BIOMET. DEVICE HISTORY RECORD AND RAW MATERIAL CERTIFICATE WAS REVIEWED. NO DEVIATIONS OR ANOMALIES RELEVANT TO THE EVENT WAS IDENTIFIED. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING RMW: 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, AS THE COMPONENTS ARE NOT RETURNED, EXAMINATION OF THE COMPONENT SURFACE CANNOT BE DONE. REDUCED PERFORMANCE OF IMPLANT, IMPLANT BREAKAGE, ABRASIVE WEAR DUE TO AGING OF MATERIAL. NOT POSSIBLE, ACCORDING TO MATERIAL COMPATIBILITY SPECIFICATION THE MATERIAL HAS BEEN TESTED. FURTHER A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. 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). POSSIBLE, AS THE COMPONENT ARE NOT RETURNED, EXAMINATION CANNOT BE PERFORMED. HOWEVER, A SYSTEMATIC ISSUE WITH MATERIAL PROPERTIES WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. ABRASIVE WEAR, OSTEOLYSIS DUE TO DESIGN SPECIFICATION NOT MET. NOT POSSIBLE, AS THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. 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, AS X-RAY IMAGES ARE NOT PROVIDED, THIS POSITIONING CANNOT BE CONFIRMED. 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 INSUFFICIENT IN PROVIDED INFORMATION, THIS CAUSE CANNOT BE EXCLUDED. DISLOCATION, SUBLUXATION, ABRASIVE WEAR, LEG LENGTH DISCREPANCY, IMPINGEMENT, LIMITED RANGE OF MOTION DUE TO SOFT TISSUE LAXITY. POSSIBLE, AS CONDITION OF SOFT TISSUE IS UNKNOWN, THIS CAUSE CANNOT BE EXCLUDED. INCREASED WEAR DUE TO INADEQUATE HANDLING OF THE MEDICAL DEVICE IN THE OR LEADING TO CONTAMINATED DEVICE (E.G. FOREIGN PARTICLES PRESENT IN COP AND COC PAIRING POSTOPERATIVELY LEADING TO INCREASED WEAR). POSSIBLE, AS THE CONDITION OF THE COMPONENT CANNOT BE EXAMINED, THE PRESENCE OF FOREIGN PARTICLES CANNOT BE EXCLUDED. INCREASED WEAR, DAMAGED IMPLANT DUE TO INADEQUATE HANDLING OF THE MEDICAL DEVICE IN THE OR LEADING TO DAMAGED DEVICE. POSSIBLE, AS THE CONDITION OF THE COMPONENT CANNOT BE EXAMINED, THE PRESENCE OF FOREIGN PARTICLES 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. POSSIBLE, AS THE PROVIDED INFORMATION IS INSUFFICIENT TO EXCLUDE THIS CAUSE. 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 THE INFORMATION OF STEM AND CUP IS MISSING, A COMPLETE COMPATIBILITY CHECK CANNOT BE PERFORMED. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO LISTHESIS III PROXIMAL FEMORAL STEM, EXCESSIVE ANTEVERSION OF CUP AND POLYETHYLENE WEAR. THE XPE LINER WAS REPLACED, BUT IT IS UNCLEAR WHETHER THE BIOLOX HEAD WAS ALSO REVISED. THE REPORTED FIRST IMPLANTATION DATE IS (B)(6) 2012; HOWEVER, THE MANUFACTURING DATE OF THE HEAD IS APRIL 01, 2015. SINCE THE CORRECT DATE CANNOT BE OBTAINED AND THE POSSIBILITY OF A EARLIER REVISION CANNOT BE EXCLUDED, THE IMPLANTATION DATE IS TAKEN AS UNKNOWN. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT(S) WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. THE LISTHESIS COULD POSSIBLY BE RELATED TO THE MENTIONED EXCESSIVE ANTEVERSION OF CUP. THE REPORTED EXCESSIVE ANTEVERSION OF CUP COULD HAVE LEAD OR CONTRIBUTED TO INCREASED WEAR. HOWEVER, 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). NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(64. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON JUNE 27, 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)(4) REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT UNDERWENT REVISION SURGERY DUE TO WEAR ON AN UNKNOWN DATE. NOTE: ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600957 BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2791392

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R