BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14

    MDR report key: 7536146 · Received May 23, 2018

    Report

    Report Number
    0009613350-2018-00543
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 23, 2018
    Report Date
    October 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

    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: A TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: PAIN. 3 SIMILAR INVESTIGATED EVENTS WITHIN 1 MONTH FOR ITEM NUMBER 00877503602 HAVE BEEN FOUND. THE FOLLOWING COMPLAINTS ARE CONSIDERED: (B)(4) (COVERS PAIN, DISLOCATION, METALLOSIS, INVESTIGATION ONGOING), (B)(4) (INVESTIGATION ONGOING). RESULT: TRIGGER FOR AN ISSUE EVALUATION IS MET. HOWEVER, AS THE EVENT PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE, NO FURTHER ACTIONS ARE NEEDED. EVENT DESCRIPTION: PATIENT WAS IMPLANTED WITH A BIOLOX HEAD - XLPE LINERS ON (B)(6) 2016 AND UNDERWENT A REVISION ON (B)(6) 2018 DUE TO PAIN. REVIEW OF RECEIVED DATA: - X-RAY REVIEW CONFIRMED HETEROTOPIC OSSIFICATION ALONG THE SUPERIOR ASPECT OF FEMORAL HEAD. IT WAS ALSO OBSERVED THAT THE ACETABULAR SCREW IS PROTRUDING THROUGH THE CORTEX INTO THE MEDIAL PELVIS. NO EVIDENCE FOR MALPOSITION OR POSSIBLE LOOSENING WAS OBSERVED. - REVIEW OF SURGICAL NOTES CONFIRMED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. THE PATIENT WAS MENTIONED TO HAVE SEVERE FEMORAL HEAD ARTHRITIS, SEVERE ACETABULAR ARTHRITIS, AND DIFFUSE OSTEOPHYTES PRESENT WITH BONE ON BONE WEAR ON THE ARTICULAR SURFACES. IN THE PROCEDURE, THE SHELL WAS IMPACTED TO EXCELLENT RIM FIT AND SECURED WITH TWO SCREWS. THE POLY WAS IMPACTED INTO THE SHELL, THE FEMUR WAS RASPED, AND THE STEM WAS IMPACTED. THE OFFSET NECK WAS TRIALED TO ACHIEVE EXCELLENT STABILITY IN A FULL RANGE OF MOTION. THE HEAD WAS THEN PLACED, THE HIP REDUCED, AND EXCELLENT STABILITY AND RANGE OF MOTION WAS AGAIN NOTED. THE LIMB LENGTHS WERE VERIFIED AND THEN THE WOUND WAS CLOSED. OFFICE VISIT NOTES OBTAINED (B)(6) 2018 CONFIRM A FOLLOW UP VISIT DUE TO PAIN. MRI OBTAINED FROM THE VISIT DESCRIBES MODERATELY SEVERE ATROPHY OF THE RIGHT HIP ADDUCTOR MUSCLE. THERE WAS BELIEVED ASEPTIC LOOSENING OF THE RIGHT FEMORAL COMPONENT, THEREFORE THE PATIENT WAS RECOMMENDED TO REVISION. REVIEW OF SURGICAL NOTES DATED (B)(6) 2018 CONFIRM THAT THE PATIENT UNDERWENT REVISION DUE TO PAIN. IT WAS IMMEDIATELY NOTED, DURING THE REVISION, THAT A SIGNIFICANT AMOUNT OF HETEROTOPIC BONE WAS PRESENT AT THE LESSER TROCHANTER AND EXTENDING DISTALLY. THE HEAD AND NECK WERE REMOVED, WITH NO CORROSION OBSERVED, AND THE LINER AND TWO SCREWS WERE REMOVED. THE SURGEON WAS UNABLE TO DISLODGE TO CUP AS IT WAS WELL FIXED. IT WAS DECIDED TO NOT REVISE THE CUP. TWO NEW SCREWS WERE PLACED, THE LINER WAS IMPACTED AND THE LOCKING MECHANISM WAS CHECKED AND NOTED TO BE COMPETENT. THE SURGEON ATTEMPTED TO REMOVE THE FEMORAL COMPONENT WITH A SLAP HAMMER AND WAS UNABLE TO MOVE THE STEM. IT WAS NOTED TO BE WELL FIXED AS WELL. THE SURGEON DETERMINED THAT PAIN WAS DUE TO THE END OF THE STEM AND MODULUS OF ELASTICITY MISMATCH AND CHOSE NOT TO REVISE THE STEM. A NEW NECK WAS PLACED, TRIALED, AND REDUCED. THE SURGEON THEN INJECTED 80 MG OF DEPOMEDROL AND 20 ML OF SALINE INTO THE ANTERIOR CAPSULE AND ALONG THE ILIOPSOAS TENDON SHEATH. NO HETEROTROPIC BONE WAS REMOVED, AS THE SURGEON PLANNED TO DISCUSS FURTHER THERAPY OPTIONS. X-RAYS WERE PROVIDED THAT SUPPORT THE OP-NOTES PROVIDED BY THE SURGEON. DEVICE ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ACCORDING TO THE AVAILABLE INFORMATION, THE PRODUCT WAS DISCARDED. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. CONCLUSION: PATIENT WAS IMPLANTED WITH A BIOLOX HEAD - XLPE LINERS ON (B)(6) 2016 AND UNDERWENT A REVISION ON (B)(6) 2018 DUE TO PAIN. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., WARSAW REFERENCE NUMBER (B)(4) (MFR- 0001822565-2018-02678). ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00630505636, ITEM NAME: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL, LOT # 63324468; ITEM NUMBER: 00784800300, ITEM NAME: MODULAR NECK S 12/14 NECK TAPER USE WITH +0 HEADS ONLY, LOT # 62615576; ITEM NUMBER: 00771101600, ITEM NAME: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 16.25 STANDARD OFFSET, LOT # 63204205; ITEM NUMBER: 00625006530, ITEM NAME: BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH, LOT # 63420038; ITEM NUMBER: 00625006520, ITEM NAME: BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH, LOT #63396989; ITEM NUMBER: 00620205622, ITEM NAME: SHELL POROUS WITH CLUSTER HOLES 56 MM, LOT # 63392366. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION X-RAYS AND MEDICAL RECORDS WERE RECEIVED AND WILL BE REVIEWED WITHIN INVESTIGATION. 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)(6) REFERENCE NUMBER (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A BIOLOX CERAMIC HEAD ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY AFTER ONE AND A HALF YEAR DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378752 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2842498

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R