BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX RINGLOC 60MM SOLID ACETABULAR CUP W/ APICAL HOLE SIZE 25 W/ LOCK RING

    MDR report key: 1953076 · Received January 7, 2011

    Report

    Report Number
    1825034-2011-00006
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K070369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION - ONLY THE LOCKING RING WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES, "MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE". DIMENSIONAL EVALUATION FOUND THE LOCKING RING TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 2011. 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 (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2010. DURING THE PROCEDURE, WHEN ATTEMPTING TO INSERT THE LINER, THE LOCKING RING DISENGAGED FROM THE CUP. THE LOCKING RING WAS REINSERTED AND NUMEROUS UNSUCCESSFUL ATTEMPTS WERE MADE TO INSERT THE LINER. THE PROCEDURE WAS COMPLETED USING ANOTHER LINER THAT WAS ON HAND, BUT ONLY AFTER A DELAY OF MORE THAN HALF AN HOUR HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENEREX RINGLOC 60MM SOLID ACETABULAR CUP W/ APICAL HOLE SIZE 25 W/ LOCK RING PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 623100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R