MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED FX / ADAPTER INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	LATERALIZED 36 MM X 6 MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/21/2019
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
On (b)(6) 2019, the initial surgery of "aequlis reverse fracture" and "aequlis reverse" was performed on the left shoulder.On (b)(6) 2019, the affected area was dislocated when patient's weight was applied to the walker.The surgeon tried to reduce it that day, but it didn't work.Later, when the surgeon took a ct (date is unknown), it was found that a bone fragment was caught between the insert and the sphere and could not be reduced.On (b)(6) 2019, a revision surgery was performed.The insert was removed for reduction.

• Brand Name: AEQUALIS REVERSED FX / ADAPTER 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: 9119500
• Report Number: 3000931034-2019-00137
• Device Sequence Number: 2347140
• Product Code: KWS
• UDI-Device Identifier: 03700386931499
• UDI-Public: 03700386931499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: Lay User/Patient
• Device Expiration Date: 02/07/2024
• Device Model Number: LATERALIZED 36 MM X 6 MM
• Device Catalogue Number: DWD860
• Device Lot Number: 4835AU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/25/2019
• 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