BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO BI-METRIC HIP SYSTEM LATERALIZED FEMORAL STEM

    MDR report key: 6746870 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05236
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    November 13, 2016
    Report Date
    December 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (STILL IMPLANTED). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCTS: ECHO BI-METRIC HIP SYSTEM LATERALIZED FEMORAL STEM P/N 192113 L/N 725430; G7 PPS ACETABULAR SHELL P/N 010000663 L/N 3616409BIOLOX DELTA CERMIC LINER P/N 110003626 L/N 3493620. REPORT SOURCE - (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2017-05236, 0001825034-2017-05237. STILL IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED A SUPERFICIAL SKIN INFECTION 12 DAYS POST-IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527533 ECHO BI-METRIC HIP SYSTEM LATERALIZED FEMORAL STEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 725430

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization SEE H10