MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number	42MM FOR 29MM BASEPLATE
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/15/2019
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
The glenospheres would not engage with the baseplate.The first two spheres were removed and will be sent back.The third still did not engage with baseplate; however, surgeon left in patient.Unknown impact to patient at this time? added an extra hour of or time to surgery.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED II GLENOID SPHERE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8887561
• Report Number: 3000931034-2019-00116
• Device Sequence Number: 11532933
• Product Code: KWS
• UDI-Device Identifier: 03700386935916
• UDI-Public: 03700386935916
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: No Information
• Device Expiration Date: 09/27/2023
• Device Model Number: 42MM FOR 29MM BASEPLATE
• Device Catalogue Number: DWD193
• Device Lot Number: 8231AT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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