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

Model Number	10° TILTED DIAM36MM FOR 25MM
Medical Device Problem Codes	Difficult to Insert (1316); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
Dr (b)(6) put a baseplate dwd172 without any issue and added the screws.While trying to put the glenoid sphere, it was impossible to screw.After cleaning of the glenoid 4 times in a row, there was no improvement.The 4th time, when the sphere dwd180 was removed, it fell.The surgeon proposed the use of a dwd181 and faced the same issue.He tried again and while screwing, felt that the screw thread was apparently functioning correctly and at the last moment, there was a sudden jump.The surgeon concluded that the screw thread was defective.The surgery was completed with a 40 minutes delay and additional anesthesia.The 25 mm baseplate was removed and the surgeon used a 29 mm baseplate instead.
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: 8132784
• Report Number: 3000931034-2018-00157
• Device Sequence Number: 10798407
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: No Information
• Device Expiration Date: 09/20/2022
• Device Model Number: 10° TILTED DIAM36MM FOR 25MM
• Device Catalogue Number: DWD181
• Device Lot Number: 6459AS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 05/06/2019
• 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