MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REV II TI GLENOID SPHERE D42 TILTED 10 DEGREES BASEPLATE D29; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWE891
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/03/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
Shout study: subject 202-00440 following some site updates in their database, we have been made aware of some revision cases from several years ago, including this one.1st revision surgery on (b)(6) 2010 (complete: humeral and glenoid sides) reason for revision: loosening/lysis prior procedure approach: reverse no other information available.

• Brand Name: AEQ REV II TI GLENOID SPHERE D42 TILTED 10 DEGREES BASEPLATE D29
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16781861
• Report Number: 3000931034-2023-00104
• Device Sequence Number: 20432516
• Product Code: KWS
• UDI-Device Identifier: 03700386952883
• UDI-Public: 03700386952883
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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 Model Number: DWE891
• Device Catalogue Number: DWE891
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male