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

Catalog Number UNK_WTM

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Seroma (2069); Inadequate Osseointegration (2646); Fluid Discharge (2686); Joint Laxity (4526); 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 pain and fluid 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 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 analysis of the clinical data that was collected on 179 patients, the cases in this study range from 2013-2020.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced increased pain and fluid, and a loose glenoid component was found seven months after surgery, which required removal.The report states: ¿seventy-nine-year-old developed increased pain and fluid following a standard total shoulder with the ascend flex for osteoarthritis.Seven months after the index surgery, the glenoid component was found to be loose and removed arthroscopically¿.

Manufacturer Narrative

Correction: h6 device code h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted 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 analysis of the clinical data that was collected on 179 patients, the cases in this study range from 2013-2020.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced increased pain and fluid, and a loose glenoid component was found seven months after surgery, which required removal.The report states: ¿seventy-nine-year-old developed increased pain and fluid following a standard total shoulder with the ascend flex for osteoarthritis.Seven months after the index surgery, the glenoid component was found to be loose and removed arthroscopically¿.

• 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: 14150722
• MDR Text Key: 289682917
• Report Number: 3000931034-2022-00191
• 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: 04/19/2022
• 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: 79 YR