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

Model Number	DIA.429MM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
Revision surgery due to implant breakage - glenoid.(b)(6).

• Brand Name: AEQUALIS REVERSED SHOULDER PROSTHESIS
• Common Device Name: AEQUALIS REVERSED GLENOSPHERE
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 5836167
• Report Number: 3000931034-2016-00108
• Device Sequence Number: 638310
• Product Code: KWS
• UDI-Device Identifier: 03700386935930
• UDI-Public: 03700386935930
• 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 Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: DIA.429MM
• Device Catalogue Number: DWD195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 08/01/2016
• 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: 66 YR
• Patient Weight: 131