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

Model Number	HUMERAL HEAD 43X16MM
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	01/03/2020
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
"it was reported that a patient had a humeral component loosening 13 years after primary surgery, the revision is scheduled on (b)(6) 2020, patient id: (b)(6)".
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 RESURFACING 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: 9698953
• Report Number: 3000931034-2020-00013
• Device Sequence Number: 2423083
• Product Code: KWS
• UDI-Device Identifier: 03700386926945
• UDI-Public: 03700386926945
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 01/10/2012
• Device Model Number: HUMERAL HEAD 43X16MM
• Device Catalogue Number: DWD804
• Device Lot Number: 4746AF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 95