MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REV II GLENOID SPHERE DIA 33 X 25 TILTED 10 DG BASEPLATE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number DWH901

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

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 SPHERE DIA 33 X 25 TILTED 10 DG BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 19153484
• MDR Text Key: 340802947
• Report Number: 3000931034-2024-00216
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03700386955013
• UDI-Public: 03700386955013
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151293
• 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: DWH901
• Device Lot Number: 4575AT
• 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