BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP

    MDR report key: 12561835 · Received October 1, 2021

    Report

    Report Number
    1644408-2021-01060
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 27, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    PHX
    UDI-DI
    00888912144575
    PMA / PMN Number
    K100741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS PAIN AND SUBTLE SUBLUXATION. THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEM LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION THE DEVICE WAS DISPOSED OF AT HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. SURGERY WAS COMPLETED AS INTENDED. THIS INVESTIGATION IS LIMITED IN SCOPE AS ONLY PARTIAL INFORMATION WAS PROVIDED TO DJO SURGICAL FOR REVIEW. THE REVISED ITEM WAS NOT RETURNED FOR EXAMINATION AND THE LOT NUMBER WAS NOT PROVIDED. GIVEN THE LIMITED INFORMATION, A SEARCH FOR AN INVOICE (OF THE PREVIOUS SURGERY) PRODUCED NO RESULTS, THEREFORE; THE ITEM REMOVED COULD NOT BE IDENTIFIED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE LOT NUMBER ARE NECESSARY. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. CUSTOMER COMPLAINT HISTORY OF THE REPORTED ITEM SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THIS COMPLAINT WILL BE CLOSED PENDING RECEIPT OF ADDITIONAL INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT INDICATED PAIN AND SUBTLE SUBLUXATION, BUT ALSO HAD A POTENTIAL LOW GRADE INFECTION. SHE WAS GIVEN AN INTRA-OPERATION INFECTION TEST AND IT CAME BACK NEGATIVE. THE POLY LINER THICKNESS WAS INCREASED TO AN 8MM SPACER BLOCK AND NEUTRAL POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462611 RSP RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXE-PLUS PHX ENCORE MEDICAL L.P 509-00-432 UNKNOWN 00888912144575

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| O