MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE EXT CAG +10MM CAGE PEG; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number RS GLENOID PLATE EXT CAG +10MM CAGE PEG

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2023.The patient presented - in taking off the humeral head, the stem became loose and the portion proximally which had stress shielding broke free from shaft.The case report form indicates that this event is definitely not related to device, definitely related to procedure.Outcome: resolved on (b)(6) 2023.

Manufacturer Narrative

Pending investigation.D10: serial number.Item number and full description.(b)(6), 320-38-00 - 145-deg pe 38mm hum liner +0.(b)(6), 320-06-38 - glenosphere 38mm.(b)(6), 304-22-11 - 10.5mm platform fx stem right.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.

• Brand Name: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17852550
• MDR Text Key: 324705867
• Report Number: 1038671-2023-02424
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186706
• UDI-Public: 10885862186706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: RS GLENOID PLATE EXT CAG +10MM CAGE PEG
• Device Catalogue Number: 320-15-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White