BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANAWAT/BURSTEIN ACETABULAR SHELL

    MDR report key: 6739193 · Received July 24, 2017

    Report

    Report Number
    0001825034-2017-05185
    Event Type
    Injury
    Date Received
    July 24, 2017
    Report Date
    August 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK050124
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (STILL IMPLANTED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: STAINLESS STEEL CABLE/SLEEVE COMBO P/N 350806 L/N 790570; MODULAR HEAD COMPONENT P/N 163670 L/N 561090; RING LOC ACETABULAR LINER P/N 11-105924 L/N 097620; COLLARLESS BI-METRIC POROUS STEM P/N X11-180313 L/N 340400; RINCLOC AND QUICK CONNECT DRILL BIT P/N 31-323230 L/N 016260; RANAWAT/BURSTEIN ACETABULAR SHELL P/N 11-106054 L/N 7751510; TI LOW PROFILE SCREW P/N 106537 L/N 016260. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-05179, 0001825034-2017-05180, 0001825034-2017-05181, 0001825034-2017-05183, 0001825034-2017-05184, 0001825034-2017-05185, 0001825034-2017-05182.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN INITIAL PROCEDURE NINE YEARS AGO AND EXPERIENCING PAIN THROUGH THE RIGHT LEG. PATIENT IS UNAWARE IF THE SURGERY WAS PERFORMED CORRECTLY WHEN INSTALLING THE HIP. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518800 RANAWAT/BURSTEIN ACETABULAR SHELL PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 775150

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization