BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14

    MDR report key: 7595102 · Received June 13, 2018

    Report

    Report Number
    0009613350-2018-00606
    Event Type
    Injury
    Date Received
    June 13, 2018
    Date of Event
    May 14, 2018
    Report Date
    November 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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: PATIENT BONE FRACTURED. EVENT SUMMARY: PATIENT WAS IMPLANTED WITH BIOLOX HEAD - M/L TAPER NECK ON (B)(6) 2018 AND UNDERWENT A REVISION ON (B)(6) 2018 DUE TO PERIPROSTHETIC FRACTURE. REVIEW OF RECEIVED DATA: MEDICAL RECORDS FROM (B)(6) 2018 INDICATE PATIENT UNDERWENT PRIMARY TOTAL LEFT HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. DURING THE PROCEDURE IT WAS OBSERVED THAT AFTER FINAL REDUCTION THERE WAS SATISFACTORY POSITION, RANGE OF MOTION, STABILITY, ALIGNMENT, TISSUE TENSION, AND LEG LENGTH. THE FEMORAL NECK WAS CHECKED BOTH ANTERIORLY AND FOR ANY FRACTURES AND NO FRACTURES IDENTIFIED. NO COMPLICATIONS NOTED. 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: AS THE INVOLVEMENT OF THE BIOLOX HEAD WITHIN THE REPORTED PERIPROSTHETIC FRACTURE REMAINS UNKNOWN, NO SPECIFIC RISK ASSESSMENT COULD BE PERFORMED. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE BIOLOX HEAD SUBJECT TO THIS ISSUE ARE LISTED IN THE APPLICABLE RISK FILE. CONCLUSION SUMMARY: PATIENT WAS IMPLANTED WITH BIOLOX HEAD - M/L TAPER NECK ON MAY 07, 2018 AND UNDERWENT A REVISION ON (B)(6) 2018 DUE TO PERIPROSTHETIC FRACTURE. MEDICAL RECORDS FROM (B)(6) 2018 INDICATE PATIENT UNDERWENT PRIMARY TOTAL LEFT HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. DURING THE PROCEDURE IT WAS OBSERVED THAT AFTER FINAL REDUCTION THERE WAS SATISFACTORY POSITION, RANGE OF MOTION, STABILITY, ALIGNMENT, TISSUE TENSION, AND LEG LENGTH. THE FEMORAL NECK WAS CHECKED BOTH ANTERIORLY AND FOR ANY FRACTURES AND NO FRACTURES IDENTIFIED. NO COMPLICATIONS NOTED. NEITHER THE DEVICE NOR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE BIOLOX HEAD IS UNKNOWN. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, IT REMAINS UNKNOWN WHETHER THE BIOLOX HEAD CONTRIBUTED TO THE REPORTED EVENT. AN EXACT ROOT CAUSE 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 CHANGE TO INITIALY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS : ITEM: MODULAR FEMORAL STEM PRESS-FIT PLASMA, CATALOG #: 00771301200, LOT #: 63929630; ITEM: MODULAR NECK G 12/14 NECK TAPER, CATALOG #: 00784802300, LOT #: 63789800; ITEM: LINER STANDARD 32 MM I.D. FOR, CATALOG #: 00630505032, LOT #: 63855902; ITEM: BONE SCREW SELF-TAPPING 6.5 MM, CATALOG #: 00625006530, LOT #: 63991511; ITEM: BONE SCREW SELF-TAPPING 6.5 MM, CATALOG #: 00625006530, LOT #: 63970107; ITEM: SHELL POROUS WITH CLUSTER HOLES 52 MM, CATALOG #: 00620205222, LOT #: 63816375. 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. SURGICAL REPORT WAS RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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 PATIENT WAS IMPLANTED WITH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437989 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2924376

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R