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

Model Number	DIAM. 29MM LONG POST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/13/2017
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
"it was reported that a patient had a glenoid baseplate instability and anterior broken screw, with pain, 11 months post-operative.Patient id : (b)(6).Subject scheduled to have revision total shoulder arthroplasty on (b)(6) 2018.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED GLENOID BASE PLATE
• 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: 7193174
• Report Number: 3000931034-2018-00002
• Device Sequence Number: 64157
• Product Code: KWS
• UDI-Device Identifier: 03700386928239
• UDI-Public: 03700386928239
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K061439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: DIAM. 29MM LONG POST
• Device Catalogue Number: DWD067
• Device Lot Number: 6241AO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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: 52 YR
• Patient Weight: 110