BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24)

    MDR report key: 5592164 · Received April 20, 2016

    Report

    Report Number
    3002806535-2016-00188
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 22, 2016
    Report Date
    October 1, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. PMA 510(K):- 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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00187 / 00188).

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING HISTORY FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. EXAMINATION OF THE RETURNED DEVICE REVEALED EVIDENCE OF HEAVY DAMAGE, MOST LIKELY OCCURRING DURING EXTRACTION OF THE IMPLANT. DIMENSIONAL ANALYSIS FOUND DEVICE CONFORMED TO PRINT SPECIFICATIONS. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LEVEL OF DAMAGE TO THE DEVICE AND AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTIES ON (B)(6) 2016. DURING THE PROCEDURE, THE ACETABULAR LINER WAS LOOSE AND SHOWED MOVEMENT WITHIN THE SHELL. THE ACETABULAR LINER WAS REMOVED AND REPLACED WITH ANOTHER LINER. THE SECOND ACETABULAR LINER ALSO SHOWED MOVEMENT. THERE WAS NO PATIENT INJURY AND THE EVENT RESULTED IN A DELAY OF TWENTY (20) MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243781 ARCOM XL HI-WALL LINER RINGLOC-X SZ 54MM (RINGLOC SIZE 24) PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3671486

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR