BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 RINGLOC MAX-ROM ACETABULAR LINER

    MDR report key: 7762531 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06827
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    April 8, 2010
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND X-RAYS PROVIDED. REVIEW OF OPERATIVE NOTES FROM THE REVISION SURGERY NOTE THE LEFT HIP WAS UNSTABLE. PATIENT REPORTS SEVERAL EPISODES OF SUBLUXATION, ALONG WITH A PRIOR CLOSED REDUCTION DUE TO DISLOCATION. REVIEW OF X-RAYS REVEAL SLIGHTLY RETROVERTED ACETABULAR COMPONENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO MULTIPLE SUBLUXATIONS AND INSTABILITY SECONDARY TO NEUTRAL/SLIGHTLY RETROVERTED ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-363661 ¿ MODULAR HEAD ¿ 771170; 11-104056 ¿ MALLORY/HEAD ACETABULAR SHELL - 952470; THERAPY DATE: (B)(6) 2010. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 06815, 0001825034 - 2018 - 06824.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO MULTIPLE SUBLUXATIONS AND INSTABILITY SECONDARY TO NEUTRAL/SLIGHTLY RETROVERTED ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604251 E1 RINGLOC MAX-ROM ACETABULAR LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 893400

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R