BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AVENIR STEM

    MDR report key: 14632597 · Received June 8, 2022

    Report

    Report Number
    0001822565-2022-01743
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    February 27, 2022
    Report Date
    July 14, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: REPORT SOURCE: HARTFORD J.M., GRAW B.P, FROSCH D.L. (2022) REDUCED INCIDENCE OF PERIOPERATIVE PERIPROSTHETIC FRACTURES USING HYBRID RASP-IMPACTION BROACHING OVER IMPACTION BROACHING WHEN USING THE DIRECT ANTERIOR APPROACH FOR TOTAL HIP ARTHROPLASTY. ARTHROPLASTY TODAY VOL. 15 (2022) 75-80 HTTPS://WWW.ARTHROPLASTYTODAY.ORG/ARTICLE/S2352-3441(22)00069-3/FULLTEXT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. FOLLOW UP INFORMATION RECEIVED STATES PATIENT WAS OSTEOPOROTIC. MEDICAL RECORDS WERE NOT PROVIDED. ROOT CAUSE REMAINS THE SAME. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: G3; H2; H3; H6. H6 COMPONENT CODE: MECHANICAL (G04)- STEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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 PATIENT EXPERIENCED A CALCAR FRACTURE DUE TO WEDGING OF THE IMPLANT POSTOPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13687 UNKNOWN AVENIR STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other