BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 HI-WALL LINER RINGLOC-X 60/36MM

    MDR report key: 6384476 · Received March 7, 2017

    Report

    Report Number
    3002806535-2017-00112
    Event Type
    Injury
    Date Received
    March 7, 2017
    Date of Event
    January 1, 2015
    Report Date
    March 24, 2017
    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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCTS - ARCOS DISTAL FEMORAL BODY, CATALOG#: 22-300817, LOT#: 998950; FEMORAL HEAD, CATALOG#: 11-363661, LOT#: 382740; RINGLOC ACETABULAR CUP, CATALOG#: PT-106064, LOT#: 247990; RINGLOCX ACETABULAR LINER, CATALOG#: EP-053660, LOT#: 3330927. IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE US, BUT A SIMILAR DEVICE IS CLEARED UNDER 510K K023357. THIS REPORT IS NUMBER 5 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-01384 / 01387 & 3002806535-2017-00112).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE ONSET OF LEFT HIP PAIN APPROXIMATELY TWO MONTHS POST-IMPLANTATION. SUBSEQUENTLY, PATIENT RECEIVED MEDICATION FOR THE PAIN APPROXIMATELY SIX MONTHS POST-IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MEDICATION FOR PAIN EXPERIENCED APPROXIMATELY SIX MONTHS POST-IMPLANTATION DUE TO LEFT HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167352 E1 HI-WALL LINER RINGLOC-X 60/36MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3330927

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention