BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL NC 13X145MM

    MDR report key: 7303322 · Received February 28, 2018

    Report

    Report Number
    0001825034-2018-01585
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 22, 2016
    Report Date
    June 13, 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). CONCOMITANT PRODUCT(S): A 192013, ECHO POR FMRL NC 13X145MM, 953180; 010000667, G7 PPS LTD ACET SHELL 60G, 3358483; 650-1162, DELTA CER FEM HD 32/0MM T1, 2015021895; 110003629, BIOLOX DELTA CER LNR 32MM G,3244223. 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 - 01585, 0001825034 - 2018 - 01586.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT REQUIRED EXTRA SUTURES TO ADDRESS CICATRICE (SCAR) PROBLEMS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146137 ECHO POR FMRL NC 13X145MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 953180

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R