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

Model Number DWF511

Device Problem Missing Value Reason (3192)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent revision surgery due to instability / dislocation.Patient id: (b)(4).

• Brand Name: AEQUALIS ASCEND FLEX TRAY
• 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: 6746273
• MDR Text Key: 81112143
• Report Number: 3000931034-2017-00143
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386942419
• UDI-Public: 03700386942419
• 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
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: DWF511
• Device Catalogue Number: TH +6 ECC. 1.5 DIAM 40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2017
• 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: 78 YR
• Patient Weight: 77