BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X ARCOMXL STD 58/36MM 25

    MDR report key: 5457588 · Received February 24, 2016

    Report

    Report Number
    3002806535-2016-00078
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    December 7, 2015
    Report Date
    June 16, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. DEVICE AVAILABILITY - THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SEND TO THE FDA TO PROVIDE RESULTS. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) 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.

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, THE ACETABULAR LINER SHOWED EVIDENCE OF ABRASION, DEEP SCRATCHES, AND MULTIPLE INDENTATIONS HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00078 & 1825034-2016-02024).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 DUE TO INSTABILITY AND AUDIBLE NOISE. THE FEMORAL HEAD, ACETABULAR LINER AND LOCKING RING WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-IMPLANTATION DUE TO INSTABILITY AND AUDIBLE NOISE. THE FEMORAL HEAD, ACETABULAR LINER AND LOCKING RING WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114530 RINGLOC-X ARCOMXL STD 58/36MM 25 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3578397

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R