BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X46MM

    MDR report key: 8700337 · Received June 14, 2019

    Report

    Report Number
    0001822565-2019-02464
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DOB - UNKNOWN DATE IN JANUARY 1962.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034-2019-04212.

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034-2019-04212.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PATIENT IDENTIFIER: (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: UNK, UNK HEAD, LOT: UNK; PART: 110024465, G7 DUAL MOBILITY LINER 46MM G, LOT: 143090; PART: UNK, UNK STEM, LOT: UNK; PART: EP-200152, ACT ARTIC E1 HIP BRG 28X46MM, LOT: 726800; PART: 010000666, G7 PPS LTD ACET SHELL 58G, LOT: 6320695. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: HEAD: 0001822565-2019-02464, LINER: 0001825034-2019-02566.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED AND SUBSEQUENTLY WAS REVISED AGAIN APPROXIMATELY 2 WEEKS LATER DUE TO DISLOCATION. THE STEM, LINER AND HEAD WERE REVISED DURING THIS SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493811 ACT ARTIC E1 HIP BRG 28X46MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 726800

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R