MAUDE Adverse Event Report: TORNIER INC. AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM; SHOULDER JOINT METAL/POLYMER PROSTHESIS

Catalog Number 6131390P

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that subject (b)(6) has had several months of recurrent anterior dislocations.Patient said they typically occur during sweeping or any activities outside the body and that they do reduce if he relaxes his shoulder.Will undergo a revision surgery to address instability issues.

• Brand Name: AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM
• Type of Device: SHOULDER JOINT METAL/POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: matt kennedy ; 10801 nesbitt ave s; bloomington, MN 55437 ; 9526837482
• MDR Report Key: 8052311
• MDR Text Key: 126581537
• Report Number: 3004983210-2018-00066
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6131390P
• Device Lot Number: 6988AR004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• 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: LATERALIZED INSERT 42MM X 6MM (TOF LEGAL MFG); PERFORM REV LATERALIZED BASEPLATE (+6MM), 29MM; PERFORM REVERSE ECCENTRIC GLENOSPHERE (+4MM), 42MM
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR