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

Model Number	DIAM. 36MM +9MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2015: initial rsa surgery.On (b)(6) 2015: observed bone resorption by notching in x-ray at 6 months check.On (b)(6) 2016: seems the bone resorption has stopped.On (b)(6) 2018: glenoid component elimination.Bone grafting.
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED II INSERT
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7525301
• Report Number: 3000931034-2018-00073
• Device Sequence Number: 1254281
• Product Code: KWS
• UDI-Device Identifier: 03700386916557
• UDI-Public: 03700386916557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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
• Operator of Device: No Information
• Device Expiration Date: 02/29/2020
• Device Model Number: DIAM. 36MM +9MM
• Device Catalogue Number: DWB994
• Device Lot Number: 3730AP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR