BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 15803148 · Received November 16, 2022

    Report

    Report Number
    0009613350-2022-00597
    Event Type
    Injury
    Date Received
    November 16, 2022
    Report Date
    January 26, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE-FOREIGN- FRANCE. 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 INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H6, H10. 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. HOWEVER, THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    A STUDY REPORTED ONE PATIENT, WITHIN THE ORIF GROUP, HAD A TOTAL HIP ARTHROPLASTY AND MONTHS LATER, UNDERWENT IMPLANTATION OF A LOCKING PLATE FIXATION SYSTEM DUE TO A PERIPROSTHETIC FRACTURE. SUBSEQUENTLY, THE PATIENT DEVELOPED AN UNKNOWN SURGICAL SITE INFECTION. NO FURTHER DISCUSSION OR INFORMATION REGARDING INTERVENTION OR OUTCOME WAS PROVIDED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349628 UNKNOWN NCB PLATE TRAUMA PROSTHESIS HRS ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other