MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ021

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.A medwatch form was received from the user facility, the information on this medwatch form 3500a was completed by wright medical technology with information received from the user facility.Any missing or incomplete data on form 3500a are the result of information not being provided by the reporter.

Event Description

It was reported that the glenosphere would not attach to the baseplate after multiple attempts and resulted in having to open a new implant.The patient was not harmed, but this added about 20 minutes to the overall procedure.

Manufacturer Narrative

H6: the device was returned for investigation and found not to be in the condition as described in the event description.Upon inspection, the glenosphere locking screw moved freely in the glenosphere capture plate.The glenosphere was assembled to a perform reversed baseplate.The screw was inserted in the baseplate and engaged as intended.The glenosphere screw was able to exit and re-enter the baseplate freely during functional testing.

• Brand Name: PERFORM REVERSED
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington, mn
• MDR Report Key: 10439859
• MDR Text Key: 204014771
• Report Number: 3004983210-2020-00021
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DWJ021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 07/27/2020
• Patient Sequence Number: 1