BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TESS HUM STEM SMALL

    MDR report key: 20491550 · Received October 21, 2024

    Report

    Report Number
    3006946279-2024-00075
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    May 15, 2023
    Report Date
    November 26, 2024
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    UDI-DI
    03599870074350
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. THE PRODUCTS REMAIN IMPLANTED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS COULD NOT BE PERFORMED DUE TO MISSING LOT NUMBER. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM. HOWEVER, DUE TO THE LACK OF THE LOT NUMBERS, AN ADDITIONAL LOT SEARCH COULD NOT BE PERFORMED. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT THE OSTEOLYSIS STARTED TO APPEAR SEVEN YEARS POST-OP. NO CONTRIBUTING FACTOR OF THE EVENT HAS BEEN REPORTED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ REF P1700134 LOT UNKNOWN TESS HUM CENTRED HEAD 45MM. REF P1700422 LOT UNKNOWN TESS GLENOID CEMENTED PE S1. REF P1700442 LOT UNKNOWN TESS HUM ANATOMICAL COROLLA S1. UNKNOWN PALACOS CEMENT, LOT UNKNOWN. G2 ¿ FOREIGN ¿ FRANCE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY NINE YEARS AGO. SUBSEQUENTLY, AT A FOLLOW-UP ON SEVENTEEN MONTHS AGO, REPORTED MODERATE PAIN AND DECREASED RANGE OF MOTION. RADIOGRAPHIC IMAGING DISPLAYED MIGRATION OF THE GLENOID COMPONENT, ALONG WITH OSTEOLYSIS AND RADIOLUCENCY OF BOTH THE HUMERAL AND GLENOID COMPONENTS. AT THIS TIME, NO SURGICAL INTERVENTION HAS BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931709 TESS HUM STEM SMALL TOTAL SHOULDER PROSTHESIS KWS BIOMET FRANCE S.A.R.L. N/A UNKNOWN 03599870074350

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other SEE H11 NARRATIVE