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

Model Number	SIZE MEDIUM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/23/2018
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.
Event or Problem Description
It was reported that a patient had a glenoid component loosening 13 years post-operative.The patient is looking to have a revision, but due to bone health is currently on tymlos treatment.Patient id: (b)(4).
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The revision surgery occurred on (b)(6) 2019.

• Brand Name: AEQUALIS GLENOID KEELED
• 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: 7548930
• Report Number: 3000931034-2018-00076
• Device Sequence Number: 13511134
• Product Code: KWS
• UDI-Device Identifier: 03700386915420
• UDI-Public: 03700386915420
• 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: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: Lay User/Patient
• Device Expiration Date: 08/31/2012
• Device Model Number: SIZE MEDIUM
• Device Catalogue Number: DWB211
• Device Lot Number: 9553AF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/21/2019
• 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: 85 YR
• Patient Weight: 73