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

Model Number	DIAM 36MM +6MM A 12.5°
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	08/20/2019
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
When the patient was seen by the surgeon for his 2 week follow up appointment the x-ray showed that the assembly screw had started to back out and the proximal body was disassociating from the distal stem from a device of another legal manufacturer.Therefore, ascend flex reversed tray and reversed insert that were assembled onto the device from other legal manufacturer were explanted as a consequence of the explantation of the device from the other legal manufacturer.The explantation of the aequalis ascend flex components is the consequence of the explantation of the device components of the other legal manufacturer.

• Brand Name: AEQUALIS ASCEND FLEX 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: 9079531
• Report Number: 3000931034-2019-00136
• Device Sequence Number: 2976789
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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 Model Number: DIAM 36MM +6MM A 12.5°
• Device Catalogue Number: DWF361B
• Device Lot Number: AC5040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/17/2019
• 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