BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED GLENOID 22MM LINER

    MDR report key: 8293718 · Received January 31, 2019

    Report

    Report Number
    0001825034-2019-00415
    Event Type
    Injury
    Date Received
    January 31, 2019
    Report Date
    April 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    CUSTOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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. UNIQUE IDENTIFIER (UDI) #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: CP0001581, CONSTRAINED GLENOID LOCK RING, LOT UNK; 211230, COMPR SRS MOD STEM - 6X75MM, LOT 541500; 211216, COMPR SRS PROX BDY - SM 58MM, LOT 688930; CP0001584, COMPR SRS TMR BODY 61MM W THDS, LOT UNK; CP0001583, CONST 22MM HMRL HEAD W SCREW, LOT UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING A REVISION OF A CANNULATED CONSTRAINED CUP TO A REVERSE BASEPLATE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87939 CONSTRAINED GLENOID 22MM LINER PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 734120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other