BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NON-CONTACTING BRIDGING PLATE

    MDR report key: 15819919 · Received November 17, 2022

    Report

    Report Number
    0009613350-2022-00569
    Event Type
    Injury
    Date Received
    November 17, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: LITERATURE- JOURNAL ARTICLE. COMPARISON OF THE FUNCTIONAL OUTCOMES AFTER TREATMENT OF PERIPROSTHETIC HIP FRACTURES WITH FEMORAL STEM LOOSENING: LOCKING PLATE FIXATION WITH OR WITHOUT FEMORAL STEM REVISION. TRISTAN VIALLA, DONG TRAN-MINH, FLORIAN BARBOTTE, ALEXANDRE HERAULT ,MATTHIEU EHLINGER, XAVIER OHL, HENRI FAVREAU, RENAUD SIBONI. HTTPS://DOI.ORG/10.1016/J.OTSR.2022.103300. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. THE DEVICE IS USED FOR TREATMENT.  MEDICAL RECORDS WERE NOT PROVIDED.  A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.    IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A STUDY REPORTED THAT ONE PATIENT, HAD A TOTAL HIP ARTHROPLASTY AND MONTHS LATER, UNDERWENT IMPLANTATION OF A LOCKING PLATE FIXATION SYSTEM DUE TO A PERIPROSTHETIC FRACTURE. SUBSEQUENTLY, HAD FIXATION FAILURE WITH DISASSEMBLY OF THE PLATE AND SCREWS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767800 UNKNOWN NON-CONTACTING BRIDGING PLATE UNKNOWN HRS ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other| H