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

Model Number	DIA.36 TILTED 10°
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	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that a patient had been experiencing a loosening of the glenoid component.Patient will undergo a revision surgery (unknown date at that time).Patient id: (b)(6).
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that a patient underwent revision surgery due to loosening of the glenoid component.Reverse shoulder arthroplasty converted to humeral hemiarthroplasty.Stem remained the same implanted from their primary surgery.(b)(6).

• Brand Name: AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOID SPHERE
• 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: 7104518
• Report Number: 3000931034-2017-00184
• Device Sequence Number: 782735
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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: 02/28/2017
• Device Model Number: DIA.36 TILTED 10°
• Device Catalogue Number: DWD181
• Device Lot Number: 1718AL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 04/05/2018
• 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: 88 YR
• Patient Weight: 51