MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Device Problem Installation-Related Problem (2965)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.Additional comments: associated devices were removed during the revision surgery, as a consequence of the issue encountered with the glenosphere (aequalis reversed humeral stem, metaphysis and humeral insert).

Event Description

Indication : the patient underwent a surgery to get a total reverse shoulder prosthesis implanted in (b)(6)-2012, due to inferior bony gleno-humeral impingement.Upon revision surgery in (b)(6)-2018, the prosthesis construct could not be clearly identified while reviewing the pre op x-ray files.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• 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 ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8385975
• MDR Text Key: 137670892
• Report Number: 3000931034-2019-00044
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/04/2019
• 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