MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS ASCEND FLEX TITANIUM HUMERAL STEM; PROSTHESIS SHOULDER JOINT METAL/POLYMER

Catalog Number UNK_WTB

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

Patient Problem Scar Tissue (2060)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

This record is a consolidation of events summarized as part of literature review, when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged arthrofibrosis, which required revision surgery, could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of national registry released by the australian orthopaedic association national joint replacement registry.The report provides information on the usage and outcomes of the aequalis fx shoulder system.This report includes analysis of the clinical data that was collected on 476 patients, the cases in this study range from 16 april 2004 and 9 march 2022.This report was generated on march 11, 2022.During the review of the registry, it was not possible to establish specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient experienced arthrofibrosis, which required revision surgery.

Event Description

The manufacturer became aware of national registry released by the australian orthopaedic association national joint replacement registry.The report provides information on the usage and outcomes of the aequalis fx shoulder system.This report includes analysis of the clinical data that was collected on 476 patients, the cases in this study range from 16 april 2004 and 9 march 2022.This report was generated on march 11, 2022.During the review of the registry, it was not possible to establish specific device details, patient information, and no additional device information will be made available.It was reported that 1 patient experienced arthrofibrosis, which required revision surgery.

Manufacturer Narrative

Please note correction of the product details.

• Brand Name: UNKNOWN AEQUALIS ASCEND FLEX TITANIUM HUMERAL STEM
• Type of Device: PROSTHESIS SHOULDER JOINT METAL/POLYMER
• 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: 14569235
• MDR Text Key: 293191315
• Report Number: 0001649390-2022-00013
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• 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): Other; Required Intervention