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

Model Number	CEMENTED DIAM 12MM L100MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/29/2019
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
"on the surgery on (b)(6) 2018, the implant at the glenoid side was removed and the humeral implant was replaced temporarily to the humeral head.At that time, the infection was relatively mild, so the stem implant was left.But this time, the infection was serious, so the surgeon decided to perform revision surgery on (b)(6) and remove the stem implant.(the implanted date was 2014)".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED HUMERAL STEM
• 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: 8792852
• Report Number: 3000931034-2019-00109
• Device Sequence Number: 16655026
• Product Code: KWS
• UDI-Device Identifier: 03700386916250
• UDI-Public: 03700386916250
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: CEMENTED DIAM 12MM L100MM
• Device Catalogue Number: DWB950
• Device Lot Number: 8755AN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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
• Patient Age: 88 YR