MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS SHOULDER SYSTEM; AEQUALIS STEM

Device Problems Device Slipped (1584); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 06/15/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery for pain, loosening/lysis, rotator cuff insufficiency.Patient id: (b)(4).

• Brand Name: AEQUALIS SHOULDER SYSTEM
• Type of Device: AEQUALIS STEM
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: segolene pollet ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 56523515
• MDR Report Key: 5284530
• MDR Text Key: 33259987
• Report Number: 3000931034-2015-00244
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• 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: 11/12/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/10/2015
• 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: 54