BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 STD

    MDR report key: 6578396 · Received May 19, 2017

    Report

    Report Number
    3002806535-2017-00405
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 21, 2017
    Report Date
    April 6, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED AFTER VISUAL INSPECTION OF RETURNED PRODUCT WHICH SHOWED A FRACTURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE EXACT CAUSE FOR THE FRACTURE OF THE LINER CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED BUT THERE MAY HAVE BEEN MANY CONTRIBUTING FACTORS SUCH AS PATIENT ACTIVITY, IMPLANT POSITIONING AND SOFT TISSUE LAXITY. THE IMPLANTS WERE REVISED DUE TO ¿PAIN AND A NOISY HIP¿ IT IS LIKELY THIS WAS AS A RESULT OF FRACTURE OF THE ACETABULAR LINER, HOWEVER, THE REASON FOR THIS FRACTURE IS NOT CLEAR. IT IS POSSIBLE THAT THE REASON FOR THE FRACTURE WAS MULTIFACTORIAL. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT OCCURRED IN (B)(6). 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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K023357. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAS BEEN INDICATED FOR HIP REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO POLY WEAR. THE PATIENT HAD PRESENTED WITH PAIN AND NOISY HIP. NO REVISION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358708 RINGLOC-X E1 STD PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 2712207

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention BIOLOX DELTA CERAMIC HEAD PN:650-0834 LN: 2737734| EXCEED ABT RINGLOC SHELL PN:131350HA LN:2915731