BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL HEAD

    MDR report key: 6815086 · Received August 23, 2017

    Report

    Report Number
    0002648920-2017-00534
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    November 29, 2007
    Report Date
    October 20, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. OP NOTES CONFIRM REVISION DUE TO DISLOCATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: VERSYS HIP SYSTEM FEMORAL HEAD: P/N 00801802803, L/N 60614240; TRILOGY ACETABULAR SYSTEM LINER: P/N 00610505828, L/N 60269772; FEMORAL STEM: P/N 00784701320, L/N 80130875; BONE SCREW: P/N 00625006525, L/N 60657574; BONE SCREW: P/N 00625006525, L/N 60657574; SHELL POROUS WITH CLUSTERS: P/N 00620005622, L/N 6061502. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565-2017-06073.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN MONTHS POST-IMPLANTATION DUE TO DISLOCATION. REVISION OPERATIVE NOTES STATE THAT A LARGER FEMORAL HEAD SIZE AND A METAL ON METAL ACETABULAR CUP WERE IMPLANTED TO INCREASE STABILITY. NO COMPLICATIONS ARE NOTED ON INITIAL OR REVISION OPERATIVE NOTES.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE SEVEN MONTHS POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594319 VERSYS HIP SYSTEM FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 60614240

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R