MAUDE Adverse Event Report: SHOULDER INNOVATIONS INC. SHOULDER INNOVATIONS INSET TOTAL SHOULDER SYSTEM; TOTAL SHOULDER ARTHOPLASTY

Model Number 18mm x 48mm

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2022

Event Type  Injury  

Event Description

Infection, surgeon planned to revise implant.

• Brand Name: SHOULDER INNOVATIONS INSET TOTAL SHOULDER SYSTEM
• Type of Device: TOTAL SHOULDER ARTHOPLASTY
• Manufacturer (Section D): SHOULDER INNOVATIONS INC.; 1535 steele ave. sw; suite b; grand rapids MI 49507
• Manufacturer (Section G): SHOULDER INNOVATIONS INC.; 1535 steele ave. sw; ste b; grand rapids MI 49507
• Manufacturer Contact: jeff ondrla ; 1535 steele ave. sw; ste b; grand rapids, MI 49507 ; 6162941026
• MDR Report Key: 13992259
• MDR Text Key: 293726143
• Report Number: 3012544635-2022-00001
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 18mm x 48mm
• Device Catalogue Number: 2N2HE18048
• Device Lot Number: TFKA02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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: SHOULDER INNOVATIONS HUMERAL SHORT STEM 32MMX6MM; SI CIRCULAR IN LINE PEG GLENOID 24MMX6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male