MAUDE Adverse Event Report: TORNIER SAS AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number	TILTED 10°
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	08/06/2019
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
Screw implanted as part of a ascend flex reverse on (b)(6) 2018.Patient had discomfort and glenoid loosening (unsure as to exact date).X rays revealed inferior locking screw had snapped.
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 REVERSED GLENOID SPHERE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER SAS; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8930652
• Report Number: 3000931034-2019-00121
• Device Sequence Number: 2205931
• Product Code: KWS
• UDI-Device Identifier: 03700386917097
• UDI-Public: 03700386917097
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/14/2022
• Device Model Number: TILTED 10°
• Device Catalogue Number: DWH905
• Device Lot Number: 8355 AS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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