MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SHOULDER PROSTHESIS; AEQUALIS REVERSED GLENOID SPHERE 36MM 10° TILTED

Catalog Number	DWD181
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial 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.
Event or Problem Description
During a follow-up x-rays it was reported that a glenosphere disassociated from baseplate.No intervention listed at this time.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED SHOULDER PROSTHESIS
• Common Device Name: AEQUALIS REVERSED GLENOID SPHERE 36MM 10° TILTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5825203
• Report Number: 3000931034-2016-00103
• Device Sequence Number: 232348
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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: 07/31/2020
• Device Catalogue Number: DWD181
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2016
• Supplement Report FDA Received Date: 04/28/2017
• 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: 55 YR