MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number SPECIFIC DEVICE NOT REPORTED

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/09/2020

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2020.The patient presented had an intra-operative tuberosity fracture in addition to a deep infection.The patient was revised on (b)(6) 2020.The case report form indicates that this event is unlikely related to device, possibly related to procedure.Outcome: resolved on (b)(6) 2020.

Manufacturer Narrative

Pending investigation.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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: 17852703
• MDR Text Key: 324708626
• Report Number: 1038671-2023-02425
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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: Male
• Patient Weight: 90 KG
• Patient Race: White