MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	KEELED SIZE LARGE
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/14/2018
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
"gross loosening of glenoid with migration into axillary recess.Loosening of humeral head component with notching of the medial proximal humerus just below the implant.Patient id: (b)(6)".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS GLENOID
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7884673
• Report Number: 3000931034-2018-00130
• Device Sequence Number: 13510089
• Product Code: KWS
• UDI-Device Identifier: 03700386915437
• UDI-Public: 03700386915437
• 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: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2018

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: No Information
• Device Expiration Date: 02/29/2012
• Device Model Number: KEELED SIZE LARGE
• Device Catalogue Number: DWB212
• Device Lot Number: 6376AF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 08/20/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 11/13/2018; 06/17/2019
• 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: 51 YR
• Patient Weight: 95