BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE HUMERAL STEM

    MDR report key: 16962486 · Received May 19, 2023

    Report

    Report Number
    0001825034-2023-01137
    Event Type
    Injury
    Date Received
    May 19, 2023
    Report Date
    July 6, 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: 0001825034-2023-01136, 0001825034-2023-01138. D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE HUMERAL HEAD; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN COMPREHENSIVE REVERSE GLENOID; 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.1852-34.2022.87.4.1487. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01136-1. 0001825034-2023-01138-1. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G3; G6; H1; H2; H3; H6. H6: COMPONENT CODES: MECHANICAL (G04)- STEM. 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 ONE PATIENT WITHIN THE NO 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.

    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
    478930 UNKNOWN COMPREHENSIVE REVERSE HUMERAL STEM SHOULDER PROSTHESIS/EXTREMITIES KWS ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R SEE H10 NARRATIVE