BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/+3MM T1

    MDR report key: 6917369 · Received October 5, 2017

    Report

    Report Number
    3002806535-2017-00925
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    March 25, 2017
    Report Date
    March 21, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(6). CONCOMITANT MEDICAL PRODUCTS: 110003619, G7 CERAMIC LINER, 3230050. 010000664, G7 PPS LTD ACET SHELL 54F, 3790818. 192013, ECHO POR FMRL NC 13 X 145 MM, 751010. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (UDI) # (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. RISKS ASSOCIATED WITH REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. ASSOCIATED PACKAGE INSERT IT STATES: WARNINGS ...ACCEPTED PRACTICES IN POSTOPERATIVE CARE ARE IMPORTANT. FAILURE OF THE PATIENT TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS INVOLVING REHABILITATION CAN COMPROMISE THE SUCCESS OF THE PROCEDURE. THE PATIENT IS TO BE ADVISED OF THE LIMITATION OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE IMPLANTS FROM FULL LOAD BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED. EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, EXCESSIVE WEIGHT AND OBESITY HAVE BEEN IMPLICATED IN PREMATURE FAILURE OF CERTAIN IMPLANTS BY LOOSENING, FRACTURE, DISLOCATION, SUBLUXATION AND/OR WEAR. POSSIBLE ADVERSE EFFECTS. 8. DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS. FROM INFORMATION SUPPLIED BY THE HOSPITAL THE CAUSE OF THE REPORTED HIP DISLOCATION WAS PATIENT ACCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD A CLOSED REDUCTION PROCEDURE PERFORMED DUE TO DISLOCATION AND SUBLUXATION WHEN STRETCHING IN THE GYM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698453 DELTA CER FEM HD 32/+3MM T1 PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 2016021417

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R