BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 HI-WALL LINER RINGLOC-X 046MM

    MDR report key: 5987404 · Received September 29, 2016

    Report

    Report Number
    3002806535-2016-00769
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    August 30, 2016
    Report Date
    August 31, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING." NUMBER 9 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION/LOOSENING, MIGRATION/SUBSIDENCE, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." NUMBER 15 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET UK AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN WARSAW, INDIANA MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K023357.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. RETURN LINER WAS RECEIVED IN TWO PIECES; HOWEVER, APPROXIMATELY HALF OF THE LINER RIM WAS NOT RETURNED FOR EVALUATION. THE FEMORAL HEAD AND STEM IMPLANTED AT THE TIME OF THE EVENT ARE NOT APPROVED FOR USE WITH THIS DEVICE OR SHELL. THE FRACTURE WAS LIKELY A RESULT OF IMPINGEMENT OF THE FEMORAL HEAD AND NECK OF THE FEMORAL STEM ON THE HI-WALLED REGION OF THE RIM; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO DISLOCATION AND FRACTURE OF THE POLY LINER, PAIN, AND SQUEAKING. PATIENT WAS REPORTED TO HAVE FALLEN APPROXIMATELY TWO MONTHS PRIOR TO REVISION PROCEDURE; HOWEVER, IT IS UNKNOWN IF THE FALL AND REVISION WERE RELATED. DURING THE PROCEDURE, IT WAS FOUND THE HEAD WAS ARTICULATING WITH THE SHELL, THE LOCKING RING WAS FUSED TO THE SHELL, AND METALLOSIS FLUID IN THE JOINT WAS NOTED. THE HEAD, LINER, AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638695 E1 HI-WALL LINER RINGLOC-X 046MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 2726264

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R