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

Model Number	LONG PTC SIZE 4B A132.5° LENGTH 104MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/02/2019
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 had an instability/dislocation one month after primary surgery.The revision surgery was performed on (b)(6) 2019.Patient id: (b)(6)".

• Brand Name: AEQUALIS ASCEND FLEX
• 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: 10216957
• Report Number: 3000931034-2020-00071
• Device Sequence Number: 2404351
• Product Code: KWS
• UDI-Device Identifier: 03700386944840
• UDI-Public: 03700386944840
• 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: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2020

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: Lay User/Patient
• Device Model Number: LONG PTC SIZE 4B A132.5° LENGTH 104MM
• Device Catalogue Number: DWF614B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 07/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 98