MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID KEELED SPHERICAL BASE; SHOULDER JOINT METAL/POLYMER PROSTHESIS

Model Number	DWB213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final 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.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
Event or Problem Description
It was reported that a patient had been experiencing a loosening of the glenoid component.Subject underwent removal of implants and revision surgery.Patient id : (b)(6).

• Brand Name: AEQUALIS GLENOID KEELED SPHERICAL BASE
• Common Device Name: SHOULDER JOINT METAL/POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 6692282
• Report Number: 3000931034-2017-00135
• Device Sequence Number: 16291247
• Product Code: KWS
• UDI-Device Identifier: 03700386915444
• UDI-Public: 03700386915444
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K994393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2017

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 Model Number: DWB213
• Device Catalogue Number: SIZE XL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/07/2017
• 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: 52 YR
• Patient Weight: 84