BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RS GLENOID PLATE EXT CAG +10MM CAGE PEG

    MDR report key: 14693353 · Received June 15, 2022

    Report

    Report Number
    1038671-2022-00688
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 24, 2022
    Report Date
    March 28, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862186706
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 320-20-30, S271552 - COMPRESSION SCREW 4.5 X 30MM; 320-20-22, S123875 - COMPRESSION SCREW 4.5 X 22MM; 320-15-05, 6748335 - GLENOSPHERE LOCKING SCREW; 300-01-11, 6764620 -11MM HUMERAL STEM; 320-06-38, 6917559 - GLENOSPHERE 38MM; 320-38-00, S120082 - QUINOXE REVERSE 38MM HUMERAL LINER +0.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH POOR BONE QUALITY AND INITIAL IMPLANT CONFIGURATION, WHICH MAY HAVE PREVENTED BIOLOGIC FIXATION BETWEEN THE BONE AND CAGE (OR HEALING OF THE GRAFT TO THE NATIVE GLENOID BONE), ALLOWED THE GLENOID COMPONENTS TO LOOSEN, AND ULTIMATELY BACK OUT OF THE GLENOID. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND IMMEDIATE POST-OPERATIVE RADIOGRAPHS OF THE INDEX SURGERY WERE NOT PROVIDED. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE (D1) BRAND NAME: RS GLENOID PLATE EXT CAG +10MM CAGE PEG, COMMON DEVICE NAME: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL (D4) CATALOG NUMBER: 320-15-06, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 25-FEB-2029, UNIQUE IDENTIFIER (UDI) #: (B)(4), (D10) CONCOMITANT DEVICE(S): 320-06-38 - GLENOSPHERE 38MM 6917559, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6940176, 320-15-05 - EQ REV LOCKING SCREW 6748335, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6804659, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 6250149, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S123875, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S260170, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S271552, 320-38-00 - 145-DEG PE 38MM HUM LINER +0 S120082, (G4) PMA/510(K)NUMBER: K110708.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR POST OP THE INITIAL LEFT TSA, THIS 73 Y/O MALE PATIENT WAS REVISED DUE TO PAIN. NO KNOWN EVENT HAS BEEN COMMUNICATED. THE PATIENT DID NOT REPORT A SPECIFIC EVENT. HE PRESENTED TO THE SURGEON'S OFFICE COMPLAINING OF PAIN. X-RAYS SHOWED THAT THE BASEPLATE CONSTRUCT PULLED OUT OF THE GLENOID BONE. THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT PULLED OUT OF THE GLENOID BONE. THE SURGEON REMOVED THE HUMERAL LINER, TORQUE SCREW, HUMERAL TRAY, GLENOSPHERE SCREW, GLENOSPHERE, COMPRESSION SCREWS, & BASEPLATE. THE VOID IN THE GLENOID WAS GRAFTED WITH OPTECURE + CCC & CANCELLOUS ALLOGRAFT. THEN, A REPLICATOR PLATE, TORQUE SCREW, & HUMERAL HEAD WAS IMPLANTED. THE HEMIARTHROPLASTY WILL BE LEFT IN PLACE TO ALLOW THE BONE GRAFT IN THE GLENOID TO HEAL BEFORE REVISING TO A REVERSE SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658298 RS GLENOID PLATE EXT CAG +10MM CAGE PEG PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL KWT EXACTECH, INC. 320-10-00 UNK 10885862186706

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H