MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX SHOULDER SYSTEM; AEQUALIS ASCEND FLEX PTC STEM SIZE 1B

Catalog Number	DWF601B
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	04/14/2016
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 loosening.Patient had bone scan consistent with humeral loosening but only minimal symptoms.Followed clinically and returned 3 months after initial discovery of potential loosening decided to revise implant.(b)(6).
Additional Manufacturer Narrative
The mfr number submitted in the initial report and follow-up #01 was not correct, the mfr number was consequently corrected.The initial submission was erroneously submitted as a 5 day report and our firm was not required to initiate action to prevent an unreasonable risk of substantial harm.This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
Revision surgery for loosening.Patient had bone scan consistent with humeral loosening but only minimal symptoms.Followed clinically and returned 3 months after initial discovery of potential loosening decided to revise implant.Patient: (b)(6).
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
Revision surgery for loosening.Patient had bone scan consistent with humeral loosening but only minimal symptoms.Followed clinically and returned 3 months after initial discovery of potential loosening decided to revise implant.Patient: (b)(6).

• Brand Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
• Common Device Name: AEQUALIS ASCEND FLEX PTC STEM SIZE 1B
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5774682
• Report Number: 3000931034-2016-00081
• Device Sequence Number: 16278367
• Product Code: KWS
• UDI-Device Identifier: 03700386944482
• UDI-Public: 03700386944482
• 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,Followup
• Report Date (Section B): 06/08/2016

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: Physician
• Device Catalogue Number: DWF601B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/07/2016
• Supplement Report FDA Received Date: 07/07/2016; 07/07/2016
• 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: 71 YR
• Patient Weight: 76