MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX STEM; SHOULDER JOINT METAL PROSTHESIS

Catalog Number DWF6XX

Device Problem Missing Value Reason (3192)

Patient Problem Fibrosis (3167)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Event Description

"it was reported that a patient underwent a revision surgery due to arthrofibrosis, 3 months post-operative.Patient id: (b)(6)".

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.

Event Description

It was reported that a patient underwent a revision surgery due to arthrofibrosis, 1 year post-operative.

• Brand Name: AEQUALIS ASCEND FLEX STEM
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 7086197
• MDR Text Key: 93817648
• Report Number: 3000931034-2017-00216
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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: Physician
• Device Catalogue Number: DWF6XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 03/14/2018
• 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
• Patient Age: 50 YR
• Patient Weight: 59