BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X44MM S50 DIA28

    MDR report key: 13092822 · Received December 28, 2021

    Report

    Report Number
    0001825034-2021-03464
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    November 30, 2021
    Report Date
    March 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485051
    PMA / PMN Number
    K150522
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PRODUCTS: 110024464 888750 G7 DUAL MOBILITY LINER 44MM F; 650-1055 2963327 DELTA CERAMIC OPTION HEAD DIA2 8; 650-1066 2963360 OPTION TAPER SLEEVE TI 0MM TYPE 1. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE DEVICE REQUESTED, BUT RETAINED BY THE HOSPITAL. 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 - 2021 - 03463.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS RECEIVED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED SUPEROLATERAL DISLOCATION OF THE LEFT HIP ARTHROPLASTY THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. REVIEWS OF X-RAYS RECEIVED CONFIRM DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994095 ACT ARTIC E1 HIP BRG 28X44MM S50 DIA28 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 764520 00880304485051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE