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

Model Number	TH+0MM OFFSET 3.5MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/04/2017
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
"(b)(6) 2017: initial operation for rotator cuff tear / (b)(6) 2017: shoulder dislocation.Treated manually./(b)(6) 2017: shoulder dislocation /(b)(6) 2017: revision for shoulder dislocation.Glenoid sphere was switched to a larger size and insert and tray were replaced.The surgeon is not sure if the devices have caused the shoulder dislocation.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS ASCEND FLEX TRAY
• 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: 7036891
• Report Number: 3000931034-2017-00201
• Device Sequence Number: 11048938
• Product Code: KWS
• UDI-Device Identifier: 03700386941078
• UDI-Public: 03700386941078
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: 11/29/2021
• Device Model Number: TH+0MM OFFSET 3.5MM
• Device Catalogue Number: DWF520
• Device Lot Number: 9816AR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 05/16/2018
• 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: 58 YR
• Patient Weight: 60