MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX SHOULDER SYSTEM HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS

Model Number	43X16 HIGH OFFSET
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	05/10/2017
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
Patient feels shoulder is going to pop out of place.Patient stated it tends to happen several times a day.Patient thinks should may pop out the back of the socket.X-ray shows some bone resorption, possible stress shielding around proximal aspect of the humerus, lucency around central post.Ct scan ordered to evaluate possible glenoid loosening.Patient id: (b)(6).

• Brand Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM HUMERAL HEAD
• 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: 7344614
• Report Number: 3000931034-2018-00032
• Device Sequence Number: 13726574
• Product Code: KWS
• UDI-Device Identifier: 03700386940163
• UDI-Public: 03700386940163
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: 43X16 HIGH OFFSET
• Device Catalogue Number: DWF413
• Device Lot Number: 1327AQ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 03/16/2018
• 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: 67 YR
• Patient Weight: 52