BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/+3MM T1

    MDR report key: 8729979 · Received June 25, 2019

    Report

    Report Number
    3002806535-2019-00552
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    May 28, 2019
    Report Date
    September 14, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H6, H10. TWO RADIOGRAPHS WERE PROVIDED WITH (B)(4) FOR REVIEW: ONE ANTERO-POSTERIOR AND ONE LATERAL RADIOGRAPH. THE DATE ON WHICH THE RADIOGRAPHS WERE TAKEN HAS NOT BEEN PROVIDED, HOWEVER THE CALCAR FRACTURE IS CLEARLY VISIBLE AND THEREFORE IT IS ASSUMED THAT THE IMAGES WERE TAKEN PRIOR TO THE REVISION SURGERY. THE TAPERLOC COMPLETE SURGICAL TECHNIQUE STATES THAT 'THE TAPERLOC COMPLETE STEM IS DESIGNED TO ACHIEVE A TIGHT PRESS-FIT IN THE FEMORAL CANAL AND THUS SHOULD SIT FLUSH OR SLIGHTLY PROUD RELATIVE TO THE BROACH' POST PRIMARY RADIOGRAPHS HAVE NOT BEEN RECEIVED AND ARE REQUIRED IN ORDER TO ASSESS THE INITIAL COMPONENT SIZING, POSITIONING AND ALIGNMENT. THIS WOULD ALSO ALLOW FOR THE DEGREE OF THE REPORTED SUBSIDENCE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO STEM SUBSIDENCE SECONDARY TO FRACTURE OF THE CALCAR.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: ARCOS 12X150MM SPL TPR DIST CATALOG #: 11-300812 LOG #: 061360, MEDICAL PRODUCT: ARCOS CON SZ B HI 60MM CATALOG #: 11-301312 LOG #: 636290, MEDICAL PRODUCT: DELTA CER FEM HD 28/0MM T1 CATALOG #: 650-1158 LOG #: 2018112262, MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X44MM CATALOG #: EP-200150 LOG #: 2478400. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO STEM SUBSIDENCE SECONDARY TO FRACTURE OF THE CALCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526094 DELTA CER FEM HD 28/+3MM T1 HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2015011520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.