BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSENSUS HIP SYSTEM FEMORAL HEAD

    MDR report key: 6640447 · Received June 14, 2017

    Report

    Report Number
    2952369-2017-00042
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 15, 2017
    Manufacturer
    CONSENSUS ORTHOPEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K960156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT: CONSENSUS HIP SYSTEM (CHS) FEMORAL HEAD. SUBJECT: ENGINEERING EVALUATION. TO: CUSTOMER (B)(4) E-FOLDER. CC: MEMOS TO FILE E-FOLDER PREPARED BY: (B)(4) (SR. PRODUCT DEVELOPMENT ENGINEER). BACKGROUND: CONSENSUS ORTHOPEDICS INC. (COI) RECEIVED NOTICE ON MAY 15, 2017 OF A REVISION TOTAL HIP ARTHROPLASTY INVOLVING THE REPLACEMENT OF A LOOSE AND MAL-POSITIONED CONSENSUS HIP SYSTEM (CHS) FEMORAL HEAD. THE ORIGINAL SURGERY WAS PERFORMED BY PROF (B)(6) ON (B)(6) 2010 IN (B)(6), FOR WHICH A MALE PATIENT RECEIVED A CHS FEMORAL HEAD, A GLOBAL MODULAR HIP (GMH) APEX NECK, A GMH APEX K2 STEM, AND AN UNIDENTIFIED ACETABULAR LINER. THE REVISION SURGERY WAS PERFORMED 6-1/2 YEARS AFTER THE ORIGINAL SURGERY ON (B)(6) 2017 BY PROF (B)(6) TO REPLACE ALL ORIGINAL IMPLANTS WITH THE ZIMMER ZMR HIP SYSTEM. RADIOGRAPHS TAKEN PRIOR TO REVISION AND PHOTOGRAPHS OF THE EXPLANTS WERE SUPPLIED FOR EVALUATION. NO PHOTOGRAPHS WERE SUPPLIED FOR THE ACETABULAR CUP. NONE OF THE EXPLANTS WERE RETURNED TO COI FOR EVALUATION. PER THE CUSTOMER EXPERIENCE REPORT (CER 863) SUPPLIED BY (B)(4), THE PATIENT REPORTED SIGNIFICANT PAIN TO PROF WOOD PRIOR TO REVISION SURGERY. RADIOGRAPHS REVEALED INCORRECT SEATING OF THE FEMORAL HEAD ON THE NECK TAPER. PROF WOOD PLANNED THE REVISION SURGERY TO REPLACE THE ACETABULAR LINER, HEAD, AND POSSIBLY THE MODULAR NECK SINCE THE STEM WAS WELL FIXED. AT TIME OF REVISION, SIGNIFICANT BLACKENING OF SURROUNDING SOFT TISSUE WAS OBSERVED. THE HEAD WAS LOOSE ON THE TRUNNION, WHICH IN TURN WAS SIGNIFICANTLY WORN TO NO LONGER MATCH THE HEAD TAPER. THE MODULAR NECK WAS SIGNIFICANTLY WORN INFERIORLY BY THE HEAD. UPON REMOVAL OF THE DAMAGED NECK, THE LOCATING PIN (I.E. ANTI-ROTATION PEG) ON THE STEM CAME AWAY WITH THE NECK, REQUIRING REPLACEMENT OF THE STEM AS WELL. THUS, ALL ORIGINAL IMPLANTS WERE REPLACED AT TIME OF REVISION. DHR REVIEW: THE DEVICE HISTORY RECORD (DHR) FOR THE CHS FEMORAL HEAD WAS EVALUATED. ALL FEMORAL HEADS IN THE LOT WERE CLEANED, PACKAGED, AND EO STERILIZED PER VALIDATED PROCESSES. QC INSPECTION FOLLOWED THEIR STANDARD INSPECTION PROTOCOL FOR THE CHS FEMORAL HEAD. ALL DIMENSIONS WERE FOUND TO BE WITHIN TOLERANCE. NO DHRS WERE AVAILABLE FOR THE OFF-LABEL IMPLANTS OR FOR THE ACETABULAR CUP, OF WHICH NO INFORMATION WAS PROVIDED. NEITHER THE GMH APEX NECK OR THE GMH RSA APEX K2 STEM WERE CLEARED FOR USE WITH THE CHS HEAD. THE NECK, SOLD BY (B)(4) IN 2010, IS EQUIVALENT TO THE APEX MODULAR NECK CURRENTLY MANUFACTURED BY OMNI. THE GMH RSA APEX K2 STEM SOLD BY (B)(4) IN 2010 IS EQUIVALENT TO THE APEX K2 FEMORAL STEM CURRENTLY MANUFACTURED BY OMNI. THE GMH RSA APEX K2 STEM WAS REMOVED FROM THE (B)(6) IN (B)(6) 2012 DUE TO HIGHER THAN EXPECTED REVISION RATE. RADIOGRAPH EVALUATION: RADIOGRAPHS TAKEN PRIOR TO REVISION SURGERY WERE EVALUATED. THE FEMORAL HEAD WAS SHOWN FULLY SEATED IN THE ACETABULAR CUP, HOWEVER THE HEAD WAS ONLY PARTIALLY SEATED TO THE MALE TRUNNION OF THE MODULAR NECK AND SEVERELY ROTATED IN ABDUCTION RELATIVE TO THE MODULAR NECK AXIS. THE ACETABULAR CUP APPEARED ADEQUATELY SEATED IN THE ACETABULUM. THE FEMORAL STEM APPEARED FIRMLY SEATED AND CORRECTLY POSITIONED IN THE FEMORAL CANAL. THE MODULAR NECK APPEARED FULLY SEATED AND CORRECTLY POSITIONED IN THE STEM. PHYSICAL INSPECTION OF EXPLANT COMPONENTS: NO EXPLANTS WERE RECEIVED FOR PHYSICAL INSPECTION. PHOTOGRAPHS OF THE EXPLANTED COMPONENTS WERE EVALUATED; HOWEVER, NO PHOTOGRAPHS WERE PROVIDED FOR THE EXPLANTED ACETABULAR CUP. THE SOFT TISSUE REMOVED FROM THE PATIENT WAS SEVERELY BLACKENED. THE MODULAR NECK WAS SEVERELY WORN ON THE SUPERIOR SURFACE OF THE MALE TAPER AND ON THE INFERIOR SURFACE JUST DISTAL TO THE MALE TAPER WHERE THE FEMORAL HEAD WAS FOUND CONTACTING THE NECK AT TIME OF REVISION. THE LOCATING PIN (I.E. ANTI-ROTATION PEG) WAS FIXED TO THE MODULAR NECK, HOWEVER IT SHOULD HAVE REMAINED ON THE FEMORAL STEM. PHOTOGRAPHS OF THE FEMORAL HEAD WERE TOO SMALL FOR VISUAL EXAMINATION; HOWEVER, NO DAMAGE WAS REPORTED BY THE CUSTOMER. THE FEMORAL STEM APPEARED IN DECENT CONDITION WITH NO DAMAGE REPORTED BY THE CUSTOMER. DISCUSSION: THE PRESENT EVALUATION INCLUDED THE REVIEW OF DHR INFORMATION PROVIDED BY CONSENSUS ORTHOPEDICS, RADIOGRAPHS TAKEN PRIOR TO REVISION, AND PHOTOGRAPHS OF EXPLANTS. NO PHOTOGRAPHS WERE PROVIDED FOR THE EXPLANTED ACETABULAR CUP. NO EXPLANTS WERE RETURNED FOR PHYSICAL INSPECTION. THE DHR REVIEW REVEALED NO REJECTIONS PERTAINING TO QC INSPECTION OR PROCESSING OF THE CHS FEMORAL HEAD. NO DHRS WERE AVAILABLE FOR THE FEMORAL NECK, STEM, OR ACETABULAR CUP SINCE THEY WERE MANUFACTURED BY ANOTHER COMPANY. RADIOGRAPH EVALUATION REVEALED A SEVERELY ABDUCTED FEMORAL HEAD RELATIVE TO THE NECK AXIS. THE HEAD WAS FOUND LOOSE, BUT SEATED ON A SEVERELY DEFORMED TAPER AT TIME OF REVISION. THE NECK WAS SEVERELY WORN ON ITS INFERIOR WALL JUST DISTAL TO THE MALE TAPER WHERE THE HEAD WAS FOUND CONTACTING THE NECK. NO DISLOCATIONS OR DISSOCIATIONS BETWEEN COMPONENTS WERE APPARENT. IT IS UNKNOWN WHAT MECHANISM(S) CAUSED THE MALE TAPER ON THE NECK TO SEVERELY DEFORM, RESULTING IN ABNORMAL HEAD ROTATION AND SEVERE WEARING ON THE FEMORAL NECK. THE CHS FEMORAL HEAD WAS NOT CLEARED FOR USE WITH THE GMH APEX NECK PER THE CHS IFU AND THUS IT IS POSSIBLE THAT THE FEMALE TAPER ON THE HEAD DID NOT PROPERLY MATCH THE MALE TAPER ON THE NECK, LEADING TO ACCELERATED WEAR ON THE NECK AND LOOSENING OF THE HEAD. THE BLACKENED OR NECROTIC SOFT TISSUE REMOVED AT TIME OF REVISION WAS LIKELY CAUSED BY METALLIC WEAR DEBRIS FROM THE HEAD-NECK JUNCTION. THE REPORTED INCIDENT WAS MOST LIKELY THE RESULT OF MISMATCHING TAPER GEOMETRY BETWEEN THE HEAD AND NECK, SINCE THE MODULAR NECK WAS USED OFF-LABEL WITH THE CHS FEMORAL HEAD. THERE WAS NO EVIDENCE SUGGESTING THE INCIDENT WAS DUE TO A MANUFACTURING DEFECT OR DESIGN FLAW WITH THE CHS FEMORAL HEAD. FIGURES AND TABLES: (B)(4). EXPLANT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PATENT PRESENTED TO PROF WOOD WITH SIGNIFICANT PAIN. X-RAY SHOWED THE HEAD NOT SITTING CORRECTLY ON THE HIP TAPER AS PER SUBMITTED PHOTOS. SURGERY REVEALED SIGNIFICANT BLACKENING OF SOFT TISSUE SURROUNDING THE HIP STEM IMPLANT. THE HEAD WAS LOOSE ON THE TRUNNION. THIS WAS SHOWN TO BE BECAUSE THE END OF THE TRUNNION HAD BEEN SIGNIFICANTLY WORN AWAY SO THAT IT WAS NO LONGER MATCHING THE HEAD TAPPER. THE METAL NECK HAD BEEN INFERIORLY BY THE HEAD. NOTE: PHOTOS WERE PROVIDED WITH COMPLAINT. IMPLANTS WERE NOT RETURNED TO COI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421050 CONSENSUS HIP SYSTEM FEMORAL HEAD CONSENSUS HIP SYSTEM FEMORAL HEAD JDI CONSENSUS ORTHOPEDICS, INC. 740332

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention