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

Model Number 36MM HUMERAL LINER +0MM CONSTRAINED

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/01/2019

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2019.The patient presented on (b)(6) 2019 and post op scapula fx.The case report form indicates that this event is possibly related to device, definitely related to procedure.

Manufacturer Narrative

Pending investigation.D10: serial number: item number and full description: (b)(6), 308-05-17 - distal fixation ring ha 17.5.(b)(6), 308-02-06 - 6x120mm distal stem modular cemented.(b)(6), 308-15-12 - taper locking screw 12.5.(b)(6), 308-08-12 - xs prox body +12.5.(b)(6), 320-01-36 - 36mm glenosphere.(b)(6), 320-15-01 - eq rev glenoid plate.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.

• Brand Name: 36MM HUMERAL LINER +0MM CONSTRAINED
• 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
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17842039
• MDR Text Key: 324552386
• Report Number: 1038671-2023-02401
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086631
• UDI-Public: 10885862086631
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/19/2024
• Device Model Number: 36MM HUMERAL LINER +0MM CONSTRAINED
• Device Catalogue Number: 320-36-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2019
• 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): Death
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: White