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

Catalog Number 9999

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation.

Event Description

As reported by the equinoxe shoulder study, the 77-year-old female patient had an initial right tsa on (b)(6) 2017 and presented with aseptic glenoid loosening on (b)(6) 2020.Subject was lifting gallon of milk and had sudden acute pain in arm; xr showed radiolucency around central cage & screws.Initially revised at osh to hemiarthroplasty with retained stem and then spacer on (b)(6) 2021.The outcome of this event is considered resolved and the action taken was revision on (b)(6) 2021.The case report form indicates that this event is unlikely related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.

• 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 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18763699
• MDR Text Key: 336053734
• Report Number: 1038671-2024-00310
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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
• Date Manufacturer Received: 01/23/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian