BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE 25 MM BASEPLATE HA + ADAPTER

    MDR report key: 7845716 · Received September 5, 2018

    Report

    Report Number
    0001825034-2018-08682
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    July 30, 2018
    Report Date
    February 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED THE COMPLAINT CANNOT BE CONFIRMED SINCE MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS UNKNOWN, HOWEVER, WITH THE INFORMATION PROVIDED IT CAN BE DEDUCED THAT THERE IS 4 POSSIBLE LOT NUMBERS WITH TWO (2) POSSIBLE EXPIRATION DATES AND TWO (2) POSSIBLE MANUFACTURING DATES. LOT NUMBER: 324460 OR 457010 OR 422300 OR 349530, EXPIRATION DATE: 01/19/2028 OR 01/20/2028, (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #NI, LOT # NI, UNK HUMERAL STEM; 115340, 416960, COMP RVS HMRL TI TRAY 44 MM; XL-115363, 119070, ARCOM XL 44-36 STD HMRL BRNG; NI, NI, UNK GLENOSPHERE; NI, NI, UNK SCREWS. FOREIGN: (B)(6). DEVICE MFR DATE: 01/19/2018 OR 01/20/2018. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687425 COMPREHENSIVE REVERSE 25 MM BASEPLATE HA + ADAPTER PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R