MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II GLENOID BASEPLATE; SHOULDER JOINT METAL PROSTHESIS

Model Number	DIAM. 25 MM
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.
Event or Problem Description
(b)(6) 2015: initial rsa surgery./ (b)(6) 2015: observed bone resorption by notching in x-ray at 6 months check./ (b)(6) 2016: seems the bone resorption has stopped./ (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 GLENOID BASEPLATE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7525297
• Report Number: 3000931034-2018-00072
• Device Sequence Number: 1529035
• Product Code: KWS
• UDI-Device Identifier: 03700386935947
• UDI-Public: 03700386935947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081059
• 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: 12/31/2019
• Device Model Number: DIAM. 25 MM
• Device Catalogue Number: DWD170
• Device Lot Number: 2743AP
• 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