MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTLESS METAPHYSIS; SHOULDER JOINT METAL PROSTHESIS

Model Number	36MM
Medical Device Problem Codes	Disassembly (1168); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event	07/21/2017
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
In postop visit patients xray showed unthreaded humeral metaphysis from humeral stem.Patient had revision reverse tsa for failed implants on (b)(6) 2017.The metaphysis was found to have partially become unthreaded from humeral stem and break off at the junction in the threaded part where the teflon plug goes through.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED CEMENTLESS METAPHYSIS
• 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: 6803596
• Report Number: 3000931034-2017-00161
• Device Sequence Number: 19111461
• Product Code: KWS
• UDI-Device Identifier: 03700386936562
• UDI-Public: 03700386936562
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K131231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: Physician
• Device Expiration Date: 02/11/2021
• Device Model Number: 36MM
• Device Catalogue Number: DWE001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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