BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM HYBRID GLENOID BASE 4MM

    MDR report key: 11472665 · Received March 12, 2021

    Report

    Report Number
    0001825034-2021-00703
    Event Type
    Injury
    Date Received
    March 12, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304462625
    PMA / PMN Number
    K060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICALS PRODUCT: CATALOG #: 113042, VERSA-DIAL 46X18X53 HUM HEAD, LOT # 113042; CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 742360; CATALOG #: 113630, COMP PRIMARY STEM 10MM MINI, LOT # 278650; CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 118001. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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: 0001825034-2021-00700, 0001825034-2021-00701, 0001825034-2021-00702, 0001825034-2021-00703, 0001825034-2021-00704.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, AFTER 8 MONTHS THE PATIENT IS EXPERIENCING PAIN ON AND OFF. X-RAYS WERE OK AND THE DOCTOR SAID EVERYTHING LOOKED OKAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370123 SM HYBRID GLENOID BASE 4MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 435090 00880304462625

    Patients

    Seq Age Sex Outcome Treatment
    1 Other