MAUDE Adverse Event Report: AEQUALIS ASCEND FLEX REVERSED TRAY; SHOULDER JOINT METAL PROSTHESIS

Model Number	TH 0 OFFSET 3.5MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
It was reported that a patient had an acromial fracture (scapular spine stress fracture) not present pre-op, 1 year after primary surgery.Patient id: (b)(6)".

• Brand Name: AEQUALIS ASCEND FLEX REVERSED TRAY
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 9882235
• Report Number: 3000931034-2020-00037
• Device Sequence Number: 19515017
• Product Code: KWS
• UDI-Device Identifier: 03700386941078
• UDI-Public: 03700386941078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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 Model Number: TH 0 OFFSET 3.5MM
• Device Catalogue Number: DWF520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/26/2020
• 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: 61 YR
• Patient Weight: 97