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

Model Number	SIZE 3B 132.5° 74MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/16/2019
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
The patient underwent initial rsa on (b)(6) 2017.The implants used were ascend flex std ptc humeral stem (dwf603b), reverse insert (dwf362b), reverse tray (dwf520), reversed ii dia.25 press fit post base plate (dwd170) and rev.Ii glenoid sphere dia.25 base plate (dwd180).On (b)(6) 2017, a dislocation occured and revision surgery was performed.During this surgery, tray (dwf520), insert (dwf391b), and sphere (dwh905) were newly used.In 2019 (no date), dislocation occurred again and manual reduction was performed, but a revision surgery was to be performed again.(b)(6) 2019, revision surgery was performed: ascend flex: long ptc humeral stem 4b 132.5 ° 104mm (dwf614b), reversed insert 42mm (+) 9 b-12.5 (dwf425b), rev.Ii glenoid sphere dia.25 baseplate dia.42mm 10 tilted sphere (dwd184), ascend flex reversed tray (+) 0 1.5mm (dwf510) were newly replaced.

• Brand Name: AEQUALIS ASCEND FLEX STEM
• 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: 9079532
• Report Number: 3000931034-2019-00130
• Device Sequence Number: 19452124
• Product Code: KWS
• UDI-Device Identifier: 03700386944543
• UDI-Public: 03700386944543
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: SIZE 3B 132.5° 74MM
• Device Catalogue Number: DWF603B
• Device Lot Number: AA7244
• 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
• Patient Age: 60 YR