MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE SUP AUG, 10 DEG; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-15-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 04/23/2022

Event Type  Injury  

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

Event Description

As reported thru equinoxe shoulder study, approximately 2 years post op the initial tsa, this 57 y/o male patient was presenting with a small suspicion for possible infection, subject had labs done and met with id in greenville who prescribed antibiotics indefinitely.The case report form indicates this event is definitely not related to devices and possibly related to procedure.This event report was received through clinical data collection activities.No additional information.

• Brand Name: RS GLENOID PLATE SUP AUG, 10 DEG
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15347003
• MDR Text Key: 299146239
• Report Number: 1038671-2022-01014
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-02
• Device Catalogue Number: 320-15-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 76 KG