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

Model Number	DIAM. 25MM X 25MM LONG POST
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Disorder (2373); Joint Dislocation (2374)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 BASEPLATE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 10288148
• Report Number: 3000931034-2020-00088
• Device Sequence Number: 17009898
• Product Code: KWS
• UDI-Device Identifier: 03700386935954
• UDI-Public: 03700386935954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2024
• Device Model Number: DIAM. 25MM X 25MM LONG POST
• Device Catalogue Number: DWD171
• Device Lot Number: 8911AU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR