MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 36MM HUMERAL LINER +0 UNCONSTRAINED

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 left tsa on (b)(6) 2023.The patient presented had non-displaced calcar fracture noted at the time of humeral implantation.The case report form indicates that this event is possibly unlikely related to device, definitely not related to procedure.

Manufacturer Narrative

Pending investigation.D10: serial number item number and full description.(b)(6), 320-35-07 - small superior/posterior aug glenoid plate,left.(b)(6), 300-30-06 - equinoxe preserve stem 6mm.(b)(6), 320-31-36 - glenosphere, 36mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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: 17884979
• MDR Text Key: 325070693
• Report Number: 1038671-2023-02466
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2023
• 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: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White