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

Catalog Number UNK_WTM

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

Patient Problems Pulmonary Embolism (1498); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pulmonary embolus, poor range of motion, and persistent pain 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 a pmcf final study report that was conducted by northshore university healthsystem, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis ascend flex shoulder system¿, which is associated with the stryker ¿aequalis ascend flex shoulder ¿system.This report includes an analysis of the clinical data that was collected on 179 patients, the cases in this study ranged from 2013-to 2020.During the review of the literature, it was not possible to establish a specific device detail and patient information, and at this time no additional device information is available.It was reported that one patient experienced poor results in the total shoulder with persistent pain and poor range of motion.Following a ct scan that demonstrated, revision surgery was scheduled.The patient expired from other causes prior to that surgery.The report states: ¿eight-one year old with a reverse total shoulder for rotator cuff arthropathy was re-admitted eight days post-operatively for a pulmonary embolus.The patient recovered from this but was very limited by multiple other significant medical conditions.She had a poor result of the total shoulder with persistent pain and poor range of motion.Following a ct scan that demonstrated, revision surgery was scheduled.The patient expired from other causes prior to that surgery.¿.

• Brand Name: UNKNOWN AEQUALIS ASCEND FLEX GLENOID SPHERE
• 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: 14160294
• MDR Text Key: 289693470
• Report Number: 3000931034-2022-00196
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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: 03/28/2024
• 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: 81 YR
• Patient Sex: Female