MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS GLENOID BASEPLATE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number UNK_WTM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  Injury  

Event Description

The manufacturer received a report from the australian orthopaedic association national joint replacement registry (aoanjrr).The report provides information on the usage and outcomes of the aequalis total reverse shoulder system based on the data collected by the aoanjrr.This report includes an analysis of the clinical data that was collected from april 2004 and june 2021.During the review of the report, it was identified that 1 patient experienced incorrect sizing which required revision surgery.

Manufacturer Narrative

The reported event that one patient required revision surgery due to incorrect sizing of the implant could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the national registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Please note, that reports received from the australian registry are not published reports and therefore web link is not available.

Manufacturer Narrative

Please note correction to product code and common device name.

Event Description

The manufacturer received a report from the australian orthopaedic association national joint replacement registry (aoanjrr).The report provides information on the usage and outcomes of the aequalis total reverse shoulder system based on the data collected by the aoanjrr.This report includes an analysis of the clinical data that was collected from april 2004 and june 2021.During the review of the report, it was identified that 1 patient experienced incorrect sizing which required revision surgery.

• Brand Name: UNKNOWN AEQUALIS GLENOID BASEPLATE
• 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): 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: 15415129
• MDR Text Key: 299831071
• Report Number: 3000931034-2022-00306
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• 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