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

Model Number	REVERSED DIAM 39MM +6 STD C-7.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/19/2019
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
"it was reported that a patient underwent a revision surgery due to glenoid loosening 4 years after primary surgery.Patient id: (b)(6)".

• 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: 9731942
• Report Number: 3000931034-2020-00019
• Device Sequence Number: 361685
• Product Code: KWS
• UDI-Device Identifier: 03700386940699
• UDI-Public: 03700386940699
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 09/11/2020
• Device Model Number: REVERSED DIAM 39MM +6 STD C-7.5
• Device Catalogue Number: DWF391C
• Device Lot Number: 4294AQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 59