BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 19919110 · Received August 6, 2024

    Report

    Report Number
    1220246-2024-07049
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    June 16, 2023
    Report Date
    June 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 MONTHS AFTER THE INITIAL ARTHROPLASTY THE PATIENT REPORTED PAIN IN THE OPERATED SHOULDER DURING A HOSPITAL VISIT ON (B)(6) 2023. ON (B)(6) 2023 AN ACROMION FRACTURE HAS BEEN DIAGNOSED AND WAS TREATED CONSERVATIVE FOR 3 MONTHS.ON (B)(6) 2023 IT WAS DECIDED THAT THE CONSERVATIVE TREATMENT WAS NOT SUCCESSFUL AND THE FRACTURE DID NOT HEAL.A SECOND SURGERY, OSTEOSYNTHESIS SCAPULA SPINE WITH A PLATE FROM A DIFFERENT MANUFACTURER WAS PERFORMED WHICH RESULTED IN A HOSPITALIZATION FROM (B)(6) TO (B)(6) 2023. THE USED PLATE HAS TORN OUT ON (B)(6) 2023 AND AN ADDITIONAL REVISION WAS PERFORMED WITH A LONGER PLATE FROM ANOTHER MANUFACTURER WHICH RESULTED IN A HOSPITALIZATION FROM (B)(6) TO THE (B)(6) 2023.ON (B)(6) 2024 THE IMPLANTED PLATE HAS TORN OUT AGAIN AND ANOTHER REVISION SURGERY WITH A PLATE FROM ANOTHER MANUFACTURER HAS BEEN PERFORMED WHICH RESULTED IN A HOSPITALIZATION FROM (B)(6) UNTIL THE (B)(6) 2024. ON (B)(6) 2024 THE SURGEON LOCATED TOE PLATE CLOSE TO THE SKIN WHICH POSED THE RISK OF AN INFECTION. ACCORDING TO A CT FROM (B)(6) 2024. THE FRACTURE SEEMED TO BE STABLE.THE SURGEON DECIDED TO REMOVE THE PLATE AN REMODELED THE SOFT TISSUE. HOWEVER THE FRACTURE RECURRED AND AN ADDITIONAL HOSPITALIZATION FROM (B)(6) UNTIL (B)(6) 2024 WAS NECESSARY. THE PATIENT HAS CONSIST SHOULDER PAINT AND THE SHOULDER FUNCTIONALITY IS WORSE THAN PRIOR TO THE ARTHROPLASTY PROCEDURE.IT WAS FURTHER REPORTED THAT THE PATIENT HAD RHEUMATISM AND NO GOOD BONE QUALITY. THE SURGEON DID NOT IDENTIFY A CLEAR INDICATION THAT THE ARTHREX IMPLANT HAS CAUSED THE INITIAL ACROMION FRACTURE HOWEVER THIS CANNOT BE EXCLUDED AS A POTENTIAL CAUSE.THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL ARHTROPLASTY:AR-9560-24-2 BATCH: 15037963.AR-9564-2436-LAT BATCH: 21-02651.AR-9561-25S BATCH: 14996927.2X AR-9563-28 BATCH: 15011289.AR-9502F-36RCPC BATCH: 22.01774.AR-9501-06P BATCH: 22.02031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647291 UNK BONE FIXATION PLATE HRS ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other