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

Model Number	DIAM. 41MM X 15 MM LOW ECC. 1.5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial 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.
Event or Problem Description
The patient underwent the ascend tsa surgery on (b)(6) 2018.Humeral dislocation and a recurrence of rotator cuff tears occurred in (b)(6) 2019 and the patient still complains of pain.A revision surgery is scheduled on (b)(6) 2019.
Event or Problem Description
Surgery on (b)(6) 2019: allageneic bone was implanted (all prosthetic components remained implanted).Information provided on 11th december 2019: a revision surgery to reverse shoulder arthroplasty was performed on (b)(6) 2019 with removal of all the components implanted on (b)(6) 2018.
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.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS ASCEND FLEX 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: 8490966
• Report Number: 3000931034-2019-00046
• Device Sequence Number: 1471246
• Product Code: KWS
• UDI-Device Identifier: 03700386940033
• UDI-Public: 03700386940033
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 06/20/2022
• Device Model Number: DIAM. 41MM X 15 MM LOW ECC. 1.5
• Device Catalogue Number: DWF041
• Device Lot Number: AB2072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 01/10/2020
• 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