BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL BODY

    MDR report key: 8037925 · Received November 5, 2018

    Report

    Report Number
    0001822565-2018-06106
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    December 5, 2017
    Report Date
    February 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K113296
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 00-9981-120-32 ¿ POROUS STEM ¿ 62953743 00-2232-004-18 ¿ COCR CABLE ¿ 63775416 00-2232-004-18 ¿ COCR CABLE ¿ 63759956 00-2232-004-18 ¿ COCR CABLE ¿ 63254355 00-8018-032-14 ¿ FEMORAL HEAD 0 63780064 REPORT SOURCE (B)(4). CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 06107.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00-9981-120-32 ¿ POROUS STEM ¿ 62953743, 00-2232-004-18 ¿ COCR CABLE ¿ 63775416, 00-2232-004-18 ¿ COCR CABLE ¿ 63759956, 00-2232-004-18 ¿ COCR CABLE ¿ 63254355, 00-8018-032-14 ¿ FEMORAL HEAD 0 63780064. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 06107.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION. DURING THE SURGERY, WHILE BEING REAMED FOR A NEW STEM, THE PATIENT EXPERIENCED A BONE FRACTURE IN THE FEMUR. FRACTURE WAS FIXED WITH WIRES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION. DURING THE SURGERY, WHILE BEING REAMED FOR A NEW STEM, THE PATIENT EXPERIENCED A BONE FRACTURE IN THE FEMUR. FRACTURE WAS FIXED WITH WIRES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879524 FEMORAL BODY PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61601799

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other