BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD HUM HEAD 54DIAX22MM

    MDR report key: 7409648 · Received April 9, 2018

    Report

    Report Number
    0001825034-2018-02419
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 31, 2015
    Report Date
    June 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK992119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CP550661, BIO-MOD STEM 13MMX115 50% CFE, 891660, EP-115393, E1 44-36 STD HMRL BRNG, 875940, 11-113685, BIO-MOD RVS HMRL A TRAY, 003280, 118001, VERSA-DIAL/COMP TI STD TAPER, 007190, 115310, COMP RVRS SHLDR GLNSP STD 36MM, 996770. 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 MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02420. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT DISEASE PROGRESSION. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMI-SHOULDER ARTHROPLASTY AND WAS REVISED DUE TO UNKNOWN REASONS TO A REVERSE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEMI-SHOULDER ARTHROPLASTY AND WAS REVISED DUE TO GLENOID ARTHRITIS DISEASE PROGRESSION TO A REVERSE SHOULDER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250449 BIO-MOD HUM HEAD 54DIAX22MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 842900

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R