BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 7942772 · Received October 8, 2018

    Report

    Report Number
    0002648920-2018-00728
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    September 11, 2018
    Report Date
    January 20, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION (MRSA) LESS THAN A MONTH POST-SURGERY OF LEFT REVISION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 0100102616 WAGNER SL REVISION® HIP STEM, UNCEMENTED, ø 16/265, TAPER 12/14 LOT# 2946112 ITEM# UNKNOWN UNKNOWN CUP LOT# UNKNOWN. FOREIGN SOURCE: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED INFECTION LESS THAN A MONTH POST-SURGERY OF LEFT REVISION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784235 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS HIP LPH ZIMMER MANUFACTURING B.V. N/A 64009465

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R