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

Catalog Number 9999

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the patient had an initial left tsa on (b)(6)2012.The patient presented on (b)(6) 2023 with possible periprosthetic humerus fracture.Patient experienced no fall or trauma but presents complaining of severe shoulder pain.Suspicion for periprosthetic humerus fracture.Waiting for patient to get ct and provide us results.The case report form indicates that this event is possibly related to device and unlikely related to procedure.Outcome is continuing.Ct scan ordered and sling provided.Due to clinical study, no devices will be returned for evaluation.

• 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; 2320 nw 66th ct.; gainesville FL
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL ; 3523771140
• MDR Report Key: 18395008
• MDR Text Key: 331340447
• Report Number: 1038671-2023-03051
• 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: 12/26/2023

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 Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/26/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White