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

Model Number	36MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
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
On (b)(6) 2016: during surgery, glenoid was fractured.Stem and head were placed and physician decided to wait about 6 months.On (b)(6) 2016: when the physician removed the implants to replace them all with competitors products, metallosis was observed.
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: 6218613
• Report Number: 3000931034-2017-00005
• Device Sequence Number: 717503
• Product Code: KWS
• UDI-Device Identifier: 03700386936562
• UDI-Public: 03700386936562
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2016

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 Expiration Date: 10/12/2020
• Device Model Number: 36MM
• Device Catalogue Number: DWE001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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
• Patient Age: 66 YR