MAUDE Adverse Event Report: TORNIER INC SIMPLICITI SHOULDER STEM; SHOULDER PROTHESIS REUSABLE INSTRUMENT

Catalog Number 9722921

Device Problems Failure to Align (2522); Device-Device Incompatibility (2919)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical.

Event Description

It was reported that the surgeon was performing a simpliciti tsa with perform glenoid.Final glenoid component had been implanted and simpliciti trials were in place.While moving the shoulder through a range of motion, the surgeon felt a "catch" and upon inspection found that the glenoid implant had been dislodged and there was an associated anterior glenoid fracture.The surgeon stated that he believed one of the slits on the simpliciti trial head had caught on the edge of the glenoid component resulting in the complication.

• Brand Name: SIMPLICITI SHOULDER STEM
• Type of Device: SHOULDER PROTHESIS REUSABLE INSTRUMENT
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: mary mcnabb ; 4375 e park 30 drive; columbia city, IN 46725 ; 5743713153
• MDR Report Key: 8664368
• MDR Text Key: 146898806
• Report Number: 3004983210-2019-00022
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/03/2019

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: 9722921
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR