MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	D36MM +6MM A.12.5°
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/13/2018
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
On (b)(6) 2018, rsa operation/on (b)(6) 2018, dislocation, difficult to reduce/on (b)(6) 2018, rsa revision surgery, change to implants of larger size glenoid sphere and constraint insert.The surgeon commented "since the patient was left for seven months from his dislocation, the contracture of the soft part was bad and it was difficult to use a big sphere implant from the initial surgery.Feel that early operation was necessary for dislocation cases." revision surgery to change to implants of larger size glenoid sphere and constraint insert.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS ASCEND FLEX REVERSED INSERT
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8155528
• Report Number: 3000931034-2018-00162
• Device Sequence Number: 2165939
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: No Information
• Device Expiration Date: 05/31/2023
• Device Model Number: D36MM +6MM A.12.5°
• Device Catalogue Number: DWF361B
• Device Lot Number: AB9192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 02/12/2019
• 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: 72 YR