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

Model Number	46 X 17
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
The components have been implanted in (b)(6) and explanted in (b)(6) because of aseptic loosening of the stem and disassembly of the humeral head from its stem.Both the components have been explanted but the parts will be retained by the hospital who doesn't expect a response from the company.
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.

• Brand Name: AEQUALIS HUMERAL HEAD
• 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: 11045294
• Report Number: 3000931034-2020-00164
• Device Sequence Number: 1046913
• Product Code: KWS
• UDI-Device Identifier: 03700386915536
• UDI-Public: 03700386915536
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K994392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 03/30/2023
• Device Model Number: 46 X 17
• Device Catalogue Number: DWB246
• Device Lot Number: 004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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