MAUDE Adverse Event Report: AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number DIAM. 36 MM CENTERED FOR 25 MM BASEPLATE

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Disorder (2373); Joint Dislocation (2374)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.

Event Description

Since this patient had a proximal humeral fracture, he was using an artificial head of another company's product (j & j) only on the humeral side.Date unknown: since the loosening of the stem implant and the glenoid were worn, only the artificial head on the humerus side was removed, and cement molding was placed at the removed part.(b)(6) 2020: the initial surgery of aequalis reverse was performed.After removing the j & j implant and the cement molding that had been temporarily inserted, the bone graft from the humeral head was used for the glenoid side.(b)(6) 2020: a dislocation occurred.The glenoid implant came off from the glenoid.(b)(6) 2020: a revision surgery was performed.On the glenoid side, the bone graft and alignment pins were reoriented , and the base plate was replaced.During surgery, when replacing the glenoid implant, the stem on the humeral side also fell out, so this was also replaced.The thickness and orientation of the bone graft and the orientation of the alignment pin did not fit firmly on the glenoid implant, and this is considered to be a technical problem in which the glenoid implant had gone upward.There was no problem at the device.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 10288149
• MDR Text Key: 200015222
• Report Number: 3000931034-2020-00089
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): N
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DIAM. 36 MM CENTERED FOR 25 MM BASEPLATE
• Device Catalogue Number: DWD180
• Device Lot Number: AC8340
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR