BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM(TM) RINGLOC CONSTRAINED LINER 36MM / PLUS 5MM STANDARD FACE

    MDR report key: 6004111 · Received October 6, 2016

    Report

    Report Number
    0001825034-2016-03984
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 7, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY." UNDER WARNINGS, NUMBER 6 STATES, "PRIOR TO SEATING THE LINER INTO THE SHELL COMPONENT, ALL SURGICAL DEBRIS (TISSUE FRAGMENTS, ETC.) MUST BE REMOVED FROM THE INTERIOR OF THE SHELL COMPONENT, AS DEBRIS MAY INHIBIT THE LOCKING MECHANISM FROM ENGAGING AND SECURING THE LINER INTO THE SHELL COMPONENT." NUMBER 8 STATES, "RETAINING RING FAILURE AND/OR DISASSOCIATION, WHICH MAY BE DUE TO IMPINGEMENT, FATIGUE, AND/OR WEAR, INCREASES THE PROBABILITY OF DISLOCATION." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03984 / 03986).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: BIOMET FREEDOM CONSTRAINED FEMORAL HEAD: CATALOG#: 11-107018, LOT#: 021250. BIOMET E-POLY ACETABULAR LINER: CATALOG#: EP-108424, LOT#: 389180. BIOMET SCREW: CATALOG#: 103535, LOT#: 470330. BIOMET SCREW: CATALOG#: 103534, LOT#: 863960. BIOMET SCREW: CATALOG#: 103533, LOT#: 745740. BIOMET MALLORY HEAD FEMORAL STEM: CATALOG#: CP154576, LOT#: 553430.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. CONCOMITANT PRODUCTS: BIOMET FREEDOM CONSTRAINED FEMORAL HEAD: CATALOG#: 11-107018, LOT#: 021250. BIOMET SCREW: CATALOG#: 103535, LOT#: 470330. BIOMET SCREW: CATALOG#: 103534, LOT#: 863960. BIOMET SCREW: CATALOG#: 103533, LOT#: 745740. BIOMET MALLORY HEAD FEMORAL STEM: CATALOG#: CP154576, LOT#: 553430.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY 2 YEARS POST-IMPLANTATION DUE TO DISASSOCIATION. THE ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655673 FREEDOM(TM) RINGLOC CONSTRAINED LINER 36MM / PLUS 5MM STANDARD FACE PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 046590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R