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

Model Number	CORTILOC PEGGED GLENOID MODEL L60
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Laxity (4526)
Date of Event	07/14/2020
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
Component loosening; patient complaining of severe pain.Xrays show a loose glenoid component.Patient will be worked up for infection and get a ct scan and likely plan for a revision surgery.Ongoing adverse event.
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
Primary diagnosis: primary glenohumeral osteoarthritis the primary study surgery was performed on (b)(6) 2012 for a total shoulder arthroplasty in anatomic configuration.Adverse event described on (b)(6) 2020: glenoid component loosening of the cortiloc pegged glenoid."patient complaining of severe pain.Xrays show a loose glenoid component.Patient will be worked up for infection and get a ct scan and likely plan for a revision surgery".Revision surgery performed on (b)(6) 2020, with removal of the pegged glenoid, the humeral stem and humeral head.

• Brand Name: AEQUALIS PERFORM 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: 10460198
• Report Number: 3000931034-2020-00098
• Device Sequence Number: 2147282
• Product Code: KWS
• UDI-Device Identifier: 03700386937538
• UDI-Public: 03700386937538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 08/12/2016
• Device Model Number: CORTILOC PEGGED GLENOID MODEL L60
• Device Catalogue Number: DWE423
• Device Lot Number: 6469AK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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: 70 YR
• Patient Weight: 88