BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10

    MDR report key: 19403136 · Received May 28, 2024

    Report

    Report Number
    3005180920-2024-00365
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706049
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MAY 2024: LOT 2305399: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2023. EXPIRATION DATE: 2028-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 08 MAY 2024: ANATOMICAL SHOULDER SYSTEM 04.01.0027 HUMERAL ANATOMICAL METAPHYSIS - CEMENTLESS - 135° - 10 (K170910) LOT 1901138A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2019. EXPIRATION DATE: 2024-11-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0089 DOUBLE ECCENTER (K170910) LOT 2307565: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-MAY-2023. EXPIRATION DATE: 2028-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0095 METAL HUMERAL HEAD Ø50 (K170910) LOT 2304628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2023. EXPIRATION DATE: 2028-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0132 HC PEGGED GLENOID Ø48 (K170910) LOT 2246177: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2023. EXPIRATION DATE: 2028-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657348 ANATOMICAL SHOULDER SYSTEM STD HUMERAL DIAPHYSIS - CEMENTLESS - 10 SHOULDER HUMERAL DIAPHYSIS PHX MEDACTA INTERNATIONAL SA 2305399 07630040706049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention