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

Model Number	CEMENTED 36MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Missing Value Reason (3192)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
Event or Problem Description
The patient complained pain 16 months after the operation and the patient was treated with intra-articular cleansing and antibiotics for 6 months but since there was no improvement, all the devices were removed.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED SHOULDER PROSTHESIS 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: 6432097
• Report Number: 3000931034-2017-00074
• Device Sequence Number: 541049
• Product Code: KWS
• UDI-Device Identifier: 03700386916328
• UDI-Public: 03700386916328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2017

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: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: CEMENTED 36MM
• Device Catalogue Number: DWB960
• Device Lot Number: 0569AP006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2017
• Supplement Date Received by Manufacturer: 02/25/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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: 77 YR
• Patient Weight: 52