MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SHOULDER PROTHESIS; AEQUALIS REVERSED GLENOID SPHERE

Model Number	DIA. 36 ECC+2
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/19/2018
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
It was reported that a patient had decreasing range of motion and worsening pain due to glenoid loosening.X-rays show loosening of the glenosphere complex tilting upwards.Revision surgery was recommended to fix loose component.(b)(6).
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED SHOULDER PROTHESIS
• Common Device Name: AEQUALIS REVERSED GLENOID SPHERE
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 7812370
• Report Number: 3000931034-2018-00105
• Device Sequence Number: 2463098
• Product Code: KWS
• UDI-Device Identifier: 03700386935909
• UDI-Public: 03700386935909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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: Health Professional
• Device Expiration Date: 11/16/2021
• Device Model Number: DIA. 36 ECC+2
• Device Catalogue Number: DWD192
• Device Lot Number: 5922AR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 75 YR
• Patient Weight: 71