BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZMR BOWED STEM PROVISIONAL

    MDR report key: 8043908 · Received November 6, 2018

    Report

    Report Number
    0001822565-2018-06220
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    December 5, 2017
    Report Date
    February 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED SHOULD BE BLANK AS THE INVOLVED DEVICE IS AN INSTRUMENT, NOT AN IMPLANT. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES CONFIRMING THAT THE PATIENT EXPERIENCED A BONE FRACTURE DURING THE REAMING PROCESS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 00-9993-017-55 ¿ CONE BODY ¿ 61601799; 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. (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: 0001822565-2018-06106.

    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
    884659 UNKNOWN ZMR BOWED STEM PROVISIONAL HIP INSTRUMENT LPH ZIMMER BIOMET, INC. N/A 62953743

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other