MAUDE Adverse Event Report: TORNIER S.A.S. AEQ ASCEND FLEX LONG HUMERAL STEM 3B ANGLE 132 DEGREES5 L98MM PTC; SHOULDER JOINT METAL PROSTHESIS

Catalog Number DWF613B

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

Patient Problems Adhesion(s) (1695); Arthritis (1723); Pain (1994)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Remained implanted.

Event Description

It was reported that on (b)(6) 2018 revision surgery for pain was undertaken (removal of synthes plate).Implantation of aequalis ascend flex components in reversed configuration + perform reversed glenoid components.On (b)(6) 2019 adverse event was reported.Pt is complaining of pain in the superior shoulder and neck.Bloodwork shows elevated crp, no significant findings on ct scan- complaints consistent with symptomatic ac arthrosis and possible low grade infection.On (b)(6) 2019 patient underwent arthroscopic distal clavicle excision and adhesiolysis.Resolved without sequelae.On (b)(6) 2021 patient fell straining shoulder and fracturing left wrist.Patient was sent to physical therapy.

• Brand Name: AEQ ASCEND FLEX LONG HUMERAL STEM 3B ANGLE 132 DEGREES5 L98MM PTC
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12593055
• MDR Text Key: 276649709
• Report Number: 3000931034-2021-00323
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2021

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: DWF613B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/07/2021
• 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: 76 YR
• Patient Weight: 79