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

Model Number	DIAM.12MM LENGTH 100MM HA
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/18/2017
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
"loosening of the components causing the patient severe pain (lack of mobility, complaints of chronic pain) in the shoulder.This prosthesis was designed to safely replace and restore function to a patient's shoulder joint.Medical record number: (b)(4)".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS REVERSED II 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: 8674139
• Report Number: 3000931034-2019-00087
• Device Sequence Number: 2947848
• Product Code: KWS
• UDI-Device Identifier: 03700386936548
• UDI-Public: 03700386936548
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: No Information
• Device Expiration Date: 10/16/2017
• Device Model Number: DIAM.12MM LENGTH 100MM HA
• Device Catalogue Number: DWE050
• Device Lot Number: 9218AL012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: 69 YR