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

Model Number DWJ013

Device Problem Migration (4003)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/07/2020

Event Type  Injury  

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 patient underwent a revision surgery due to instability/dislocation of the implant.

• Brand Name: AEQUALIS PERFORM REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington, mn
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington, mn
• Manufacturer Contact: andrew melchiori ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10448985
• MDR Text Key: 204228646
• Report Number: 3004983210-2020-00022
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

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: Health Professional
• Device Model Number: DWJ013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 80