MAUDE Adverse Event Report: AEQUALIS REVERSED FRACTURE INSERT; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	LATERALIZED 36 MM X 12 MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
On (b)(6) 2020, the initial surgery of aequalis reversed fracture was performed.(b)(6) 2020, a dislocation occurred at the affected part.Operation was performed on (b)(6) 2020.The metaphysical plug and insert have been removed and replaced with a new spacer ((b)(4)) and insert ((b)(4)).Since the patient was lying down and watching his tv with his elbows on, the surgeon thinks that he was structurally vulnerable to dislocation.
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 FRACTURE INSERT
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• MDR Report Key: 10095461
• Report Number: 3000931034-2020-00068
• Device Sequence Number: 16979867
• Product Code: KWS
• UDI-Device Identifier: 03700386931512
• UDI-Public: 03700386931512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071948
• 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): 04/30/2020

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: No Information
• Device Expiration Date: 05/24/2023
• Device Model Number: LATERALIZED 36 MM X 12 MM
• Device Catalogue Number: DWD862
• Device Lot Number: 7356AT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR