MAUDE Adverse Event Report: AEQUALIS CEMENTED IMPLANTS; SHOULDER JOINT METAL PROSTHESIS

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

Patient Problems Debris, Bone Shedding (1803); Muscle Weakness (1967)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After the initial tsa surgery, the rotator cuff tear occurred and shoulder function declined.On (b)(6) 2020, all the implants were removed.Due to the bone destruction progressed too much, the surgeon gave up the placement of the new implant.

• Brand Name: AEQUALIS CEMENTED IMPLANTS
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 10142194
• MDR Text Key: 194758683
• Report Number: 3000931034-2020-00069
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• 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