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

Model Number	LOCKING SCREW DIAM.4.5 MM X 26 MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374)
Date of Event	06/05/2020
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.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
Event or Problem Description
A patient who had an initial surgery of the aequalis reverse on (b)(6) 2015, visited the outpatient department on (b)(6) 2020, and complained of pain in the affected area.Upon x-ray examination and puncture examination of the affected area, looseness of glenoid implant and infection were confirmed.Surgery was performed on (b)(6) 2020.Since the base plate on the glenoid side was unstable, all implants on the glenoid side were removed except the humeral stem implant and the metaphysis implant, and the surgery was completed.The surgeon commented:regarding the implant on the humeral side was confirmed to be stable, so it was left as it was.
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 MULTIDIRECTIONAL SCREW
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 10238770
• Report Number: 3000931034-2020-00075
• Device Sequence Number: 2654963
• Product Code: KWS
• UDI-Device Identifier: 03700386917097
• UDI-Public: 03700386917097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 04/07/2020
• Device Model Number: LOCKING SCREW DIAM.4.5 MM X 26 MM
• Device Catalogue Number: DWD126
• Device Lot Number: 3398AP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other