MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX SHOULDER SYSTEM; AEQUALIS ASCEND FLEX HUMERAL STEM

Model Number	LONG PTC SIZE 4B
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	05/02/2016
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
Revision surgery for humeral component subsidence.At a clinical visit on (b)(6) 2016, the patient was diagnosed with a low grade humeral prosthetic loosening with pseudo stability of the right (study) shoulder.The patient underwent a revision rsa on the right (study) shoulder on (b)(6) 2016.Patient id: (b)(6).
Additional Manufacturer Narrative
This is the final 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.

• Brand Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
• Common Device Name: AEQUALIS ASCEND FLEX HUMERAL STEM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5878634
• Report Number: 3000931034-2016-00120
• Device Sequence Number: 1163984
• Product Code: KWS
• UDI-Device Identifier: 03700386944833
• UDI-Public: 03700386944833
• 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: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2016

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: 08/31/2018
• Device Model Number: LONG PTC SIZE 4B
• Device Catalogue Number: DWF614B
• Device Lot Number: 1541AN001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2016
• Supplement Report FDA Received Date: 09/27/2016
• 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: 65 YR
• Patient Weight: 81