MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Device Problems Detachment of Device or Device Component (2907); Ejection Problem (4009)

Patient Problems Joint Disorder (2373); Joint Laxity (4526)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.

Event Description

Aequalis reversed prosthesis implanted on (b)(6) 2020.On (b)(6) 2020 during a consultation, we observed the disassembly of the glenoid sphere.Revision surgery and implantation of a new glenoid sphere and insert.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED INSERT
• Type of Device: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10493693
• MDR Text Key: 205711583
• Report Number: 3000931034-2020-00105
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR