BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC BI-POLAR ACETABULAR CUP 28 MM I.D / 44 MM O.D.

    MDR report key: 1904999 · Received November 22, 2010

    Report

    Report Number
    1825034-2010-00614
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    K051569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND IMPLANT DID NOT CONFORM TO BIOMET SPECIFICATIONS. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT SUBMITTED NOVEMBER 22, 2010.

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A (B)(6) LETTER FROM BIOMET ON (B)(6) 2010 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT THE MANUFACTURER REPORT NUMBER REFERENCED IN THIS MEDWATCH AND THE ATTACHED USER FACILITY REPORT ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. THIS COMPONENT IS PART OF AN EIGHT (8) UNIT LOT. ALL OF THE UNITS MANUFACTURED ARE WITHIN BIOMET'S CONTROL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2010. THE ACETABULAR LINER WOULD NOT ASSEMBLE INTO THE BIPOLAR SHELL. THE TECHNICIAN OPENED A SECOND SHELL AND HAD NO PROBLEM ASSEMBLING THE LINER INTO THE SECOND SHELL. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT AND NO DELAY IN SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2010. THE ACETABULAR LINER WOULD NOT ASSEMBLE INTO THE BIPOLAR SHELL. THE TECHNICIAN OPENED A SECOND SHELL AND HAD NO PROBLEM ASSEMBLING THE LINER INTO THE SECOND SHELL. THE PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT AND NO DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC BI-POLAR ACETABULAR CUP 28 MM I.D / 44 MM O.D. PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 546550

    Patients

    Seq Age Sex Outcome Treatment
    1