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

Model Number	DIA. 11 L130
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	08/31/2016
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 3 months post-op, the poly was disassociated from the stem.The surgeon decided to keep the stem in the patient.
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.
Event or Problem Description
Patient lifted a 2x4 on (b)(6) 2016, felt and heard a pop, severe pain, rested, sling, motrin gave no relief, follow up in office (b)(6) 2016, shows dissociation of poly from stem.Stem left in place.

• Brand Name: AEQUALIS FX2 SHOULDER PROSTHESIS
• Common Device Name: AEQUALIS FX2 HUMERAL STEM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5952037
• Report Number: 3000931034-2016-00136
• Device Sequence Number: 569646
• Product Code: KWS
• UDI-Device Identifier: 03700386956980
• UDI-Public: 03700386956980
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/31/2016

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: DIA. 11 L130
• Device Catalogue Number: DWK124B
• Device Lot Number: 7153AQ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: 08/31/2016
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 12/28/2017
• 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: 70 YR
• Patient Weight: 98