BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL NC 13X145MM

    MDR report key: 6951556 · Received October 16, 2017

    Report

    Report Number
    0001825034-2017-08668
    Event Type
    Injury
    Date Received
    October 16, 2017
    Report Date
    December 29, 2017
    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
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AVAILABLE CLINICAL RECORDS AND FOLLOW UP INFORMATION INDICATE PATIENT UNDERWENT INITIAL RIGHT HIP ARTHROPLASTY DUE TO OSTEOARTHRITIS. NO ADVERSE EVENT WERE REPORTED DURING THE PROCEDURE. HIS FASCIA WAS RUPTURED AND THIS WAS TREATED BY SUTURE TO THE FASCIA PATIENT REPORTED SEVERE PAIN ALSO. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(6). CONCOMITANT MEDICAL PRODUCTS: THE 010000664, G7 PPS LTD ACET SHELL 54F, 3790818. THE 650-1161, DELTA CER FEM HD 32/+3 MM T1, 2016021417. THE 110003619, BIOLOX DELTA CER LNR 32 MM F, 3230050. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08669. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN THAT HAS LIMITED DAILY ACTIVITY. NO REVISION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732330 ECHO POR FMRL NC 13X145MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 751010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other