BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ARTICULATION DUAL MOBILITY BEARING

    MDR report key: 7781682 · Received August 14, 2018

    Report

    Report Number
    0001825034-2018-04419
    Event Type
    Injury
    Date Received
    August 14, 2018
    Date of Event
    June 13, 2018
    Report Date
    April 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK911684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI # (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    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 - G7 DUADUAL MOBILITY ACETABULAR LINER # ITEM 110024463 LOT 637230; RINGLOC ACETABULAR DRILL BIT # ITEM 31-323240 LOT 701490; ARCOS 19X150MM SPL TPR DIST # ITEM 11-300819 LOT 637680; COCR MOD HD # ITEM 163660 LOT 043830; ARCOS CON SZ B STD 60MM # ITEM 11-301302 LOT 635080; G7 OSSEOTI MULTIHOLE 52MM E # ITEM 110010264 LOT 6222915; BONE SCREW # ITEM 00625006520 LOT 63592252; BONE SCREW # ITEM 00625006530 LOT 63458137; BONE SCREW # ITEM 00625006530 LOT 637230. (B)(6). IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TRIPPED, FELL AND HAD TO UNDERGO A REVISION SURGERY DUE TO DISLOCATION 3 MONTHS POST INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623336 ACTIVE ARTICULATION DUAL MOBILITY BEARING PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 720760

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R