MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27

Model Number	04.01.0172
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 june 2021: lot 2003845a: (b)(4) items manufactured and released on 11-jan-2021.Expiration date: 2025-12-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed by r&d department: the fracture of the acromion is known to be associated to repetitive abutment of the humerus or overtensioning of the deltoid caused by excessive humeral distalization.Given the information at hand and the absence of x-rays, it is not possible to determine the root cause of the event.No action is suggested.Another devices involved: batch review performed on 24 june 2021: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2003795:(b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0120 humeral reverse hc liner ø36/+3mm (k170452) lot 179117: (b)(4) items manufactured and released on 19-apr-2018.Expiration date: 2023-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0184 short humeral diaphysis - cementless - 11 (k180089) lot 1900960: (b)(4) items manufactured and released on 17-apr-2019.Expiration date: 2024-04-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
Primary surgery performed in (b)(6) 2021.Fracture of the acromion detected 1 month after the surgery.No revision surgery scheduled at this time.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12067299
• Report Number: 3005180920-2021-00521
• Device Sequence Number: 17228857
• Product Code: PHX
• UDI-Device Identifier: 07630040706599
• UDI-Public: 07630040706599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: 04.01.0172
• Device Catalogue Number: 04.01.0172
• Device Lot Number: 2003845A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/25/2021
• 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: 84 YR