MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWD173

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Implant Pain (4561)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

The event involves a device that is not cleared for sale in the u.S., but a similar device (dwd171) is commercially available and cleared under 510k # k131231.Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device was discarded.

Event Description

As reported: "patient underwent left primary shoulder replacement on (b)(6) 2020.Patient presented to surgeon in 2023, with a history of a painful left shoulder, and a discharging sinus (left axilla).Swabs grew the bacteria c.Acnes.Plan: remove all prosthesis (1st stage) / insert an antibiotic cement spacer; return in several months, when clinical markers indicate infection resolved, and implant a new prosthetic left shoulder joint(2nd stage).Today, all prosthesis removed, discarded.Multiple specimens taken for pathology".

• Brand Name: AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19153480
• MDR Text Key: 340722766
• Report Number: 3000931034-2024-00215
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWD173
• Device Lot Number: AC7380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female