MAUDE Adverse Event Report: TORNIER INC. SIMPLICITI SHOULDER SYSTEM; SHOULDER PROSTHESIS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 04/27/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to loosening/lysis and pain.The implanted stem and glenoid were removed and replaced.No further patient complications have been reported.

• Brand Name: SIMPLICITI SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue south; bloomington MN 55437
• Manufacturer Contact: dustin smith ; 10801 nesbitt ave south; bloomington, MN 55437 ; 9529217121
• MDR Report Key: 6437436
• MDR Text Key: 70970747
• Report Number: 3004983210-2017-00008
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2017

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?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AFFINITI GLENOID
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 84