BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X44MM

    MDR report key: 8324917 · Received February 11, 2019

    Report

    Report Number
    0001825034-2019-00485
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 16, 2019
    Report Date
    June 18, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. AN X-RAY WAS PROVIDED, HOWEVER BECAUSE IT IS NOT DATED IT IS UNKNOWN IF THE XRAY IS RELATED TO THIS COMPLAINT. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110024464 ¿ G7 DUAL MOBILITY LINER ¿ 321120. UNKNOWN ¿ HEAD ¿ UNKNOWN. UNKNOWN ¿ STEM ¿ UNKNOWN. 00625006540 ¿ BONE SCREW ¿ 63820569. 00625006540 ¿ BONE SCREW ¿ 63657711. 110010265 ¿ G7 OSSEOTI MULTIHOLE ¿ 6070686. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS 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: 0001825034-2019-00487.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT HIP SURGERY ON AN UNKNOWN DATE. THE PATIENT WAS LATER REVISED. SUBSEQUENTLY, THE PATIENT WAS REVISED AGAIN APPROXIMATELY THREE MONTHS LATER DUE TO DISLOCATION. THE BEARING AND HEAD WERE DISASSOCIATED AT REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119966 ACT ARTIC E1 HIP BRG 28X44MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 796040

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R