MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS FX2 SHOULDER PROSTHESIS; AEQUALIS FX2 STANDARD HUMERAL STEM

Model Number	Ø 13 MM LENGTH 130MM
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 19-sept-2016 under recall id 1649390-09/16/16-001-r.This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS FX2 SHOULDER PROSTHESIS
• Common Device Name: AEQUALIS FX2 STANDARD HUMERAL STEM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5949285
• Report Number: 3000931034-2016-00133
• Device Sequence Number: 863488
• Product Code: KWS
• UDI-Device Identifier: 03700386956515
• UDI-Public: 03700386956515
• 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
• 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: 01/06/2021
• Device Model Number: Ø 13 MM LENGTH 130MM
• Device Catalogue Number: DWK125B
• 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