BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL NC 16X160MM

    MDR report key: 7298711 · Received February 27, 2018

    Report

    Report Number
    0001825034-2018-01499
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    November 1, 2016
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 010000667, G7 PPS LTD ACET SHELL 60G, 3795399, 650-1161, DELTA CER FEM HD 32/+3MM T1, 2015110160, 110003629, BIOLOX DELTA CER LNR 32MM G, 3181271. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01500.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED. EPISODES OF SEVERE PAIN THAT MAY REQUIRE THE USE OF MEDICATION STRONGER THAN AN ASPIRIN DURING THREE MONTHS WHICH DECREASED TO MILD AND MODERATE PAIN DURING ONE YEAR FOLLOW UP VISIT. THE PATIENT ALSO REPORTED A MODERATE LIMP THAT REQUIRED A CANE FOR SUPPORT AND DIFFICULTY WITH DAILY ACTIVITIES DURING THREE MONTH FOLLOW UP VISIT. THE SLIGHT LIMP DID NOT REQUIRE ANY SUPPORT. SATISFACTORY RATING OF 9 WAS REPORTED DURING ONE YEAR POST OP VISIT. NO FUTHER INFORMATION WAS PROVIDED, AND THE PATIENT'S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144040 ECHO POR FMRL NC 16X160MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 890370

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R