BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN COMPREHENSIVE REVERSE BEARING

    MDR report key: 17143898 · Received June 16, 2023

    Report

    Report Number
    0001825034-2023-01302
    Event Type
    Injury
    Date Received
    June 16, 2023
    Report Date
    June 16, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01132-1, 0001825034-2023-01133-1, 0001825034-2023-01134-1, 0001825034-2023-01303. D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE HUMERAL HEAD; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE HUMERAL STEM; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE GLENOID BASEPLATE; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE TRAY; LOT#: UNKNOWN. G2: FOREIGN: ARGENTINA. G2: LITERATURE: ROSSI LA, JUANA C, FREIRAS C, BRANDARIZ R, TANOIRA I, RANALLETTA M. INFLUENCE OF THE CONSOLIDATION OF THE TUBEROSITIES ON THE CLINICAL OUTCOMES OF THE REVERSE ARTHROPLASTY IN PROXIMAL HUMERUS FRACTURES. REV ASOC ARGENT ORTOP TRAUMATOL 2022;87(4):466-475. HTTPS://DOI.ORG/10.15417/ISSN.1852-434.2022.87.4.1487. 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. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. 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 THAT A JOURNAL ARTICLE WAS RETRIEVED FROM JOURNAL OF THE ARGENTINE ASSOCIATION OF ORTHOPEDICS AND TRAUMATOLOGY 2022 THAT REPORTED A RETROSPECTIVE STUDY FROM ARGENTINA. THE PURPOSE OF THE STUDY WAS TO COMPARE THE CLINICAL OUTCOMES AND COMPLICATIONS OF A CONSECUTIVE SERIES OF PATIENTS WITH PROXIMAL HUMERUS FRACTURES (PHF) TREATED WITH REVERSE SHOULDER ARTHROPLASTY (RSA), WITH AND WITHOUT ANATOMICAL HEALING OF THE TUBEROSITIES. THE STUDY REPORTED TWO PATIENTS WITHIN THE CONSOLIDATION GROUP THAT EXPERIENCED PERIPROSTHETIC INFECTION AND REQUIRED 2-STAGE REVISION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434609 UNKNOWN COMPREHENSIVE REVERSE BEARING SHOULDER PROSTHESIS/EXTREMITIES KWS ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H