BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD RGX AUG - LG

    MDR report key: 9969722 · Received April 16, 2020

    Report

    Report Number
    0001825034-2020-01673
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    August 29, 2017
    Report Date
    August 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K173411
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE EVENT WILL BE REPORTED UNDER MEDWATCH#: 0001825034-2020-03218. 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

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMPR SRS IC SEG, CAT: 211225, LOT: UNK. COMPR SRS PROX BDY, CAT: 211218, LOT: UNK. COMPR SRS MOD STEM, CAT: 211259, LOT: UNK. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT SHOULDER HEMIARTHROPLASTY PERFORMED. AT THE ONE YEAR FOLLOW UP VISIT, THE PATIENT REPORTED SEVERE PAIN, INCREASED LIMITATION TO ADLS, AND VERY LOW SATISFACTION LEVEL. UPON XRAY REVIEW, IT WAS NOTED THAT THE PROSTHESIS HAD MIGRATED DUE TO ROTATOR CUFF INSUFFICIENCY. NO INTERVENTION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429696 COMPR SRS MOD RGX AUG - LG SHOULDER, PROSTHESIS JDC ZIMMER BIOMET, INC. 154430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.