MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS FX2 SHOULDER PROSTHESIS; AEQUALIS FX2 REVERSED INSERT

Model Number	Ø42 TH 12 TYPE STD ANGLE B
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
At 2.5 months post-op the patient came in with dislocated shoulder.After x-rays, surgeon suspected the patient had a disassociation of the poly insert and the stem.During the revision surgery, the poly was disassociated from the stem.The surgeon decided to keep the stem in the patient as it was cemented.
Additional Manufacturer Narrative
Recall information to fda done on (b)(6) 2016 under recall id (b)(4).This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.

• Brand Name: AEQUALIS FX2 SHOULDER PROSTHESIS
• Common Device Name: AEQUALIS FX2 REVERSED INSERT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5949313
• Report Number: 3000931034-2016-00134
• Device Sequence Number: 10852595
• Product Code: KWS
• UDI-Device Identifier: 03700386956997
• UDI-Public: 03700386956997
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: Ø42 TH 12 TYPE STD ANGLE B
• Device Catalogue Number: DWK252B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 12/15/2017
• 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: 77 YR
• Patient Weight: 100