MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25; SHOULDER BASEPLATE

Model Number	04.01.0152
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16-sep-2021: lot 2006949: (b)(4) items manufactured and released on 14-oct-2020.Expiration date: 2025-10-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: one week after primary rsa, a bone fracture occurs and the baseplate + glenosphere are mobilized.Traumatic events are not quoted in the report; the patient has visibly thin scapular bone and in general her bone appears to be weak and little dense, so the origin of the fracture is not defined.No reason to suspect a faulty device at the root of this adverse event.Picture investigation performed by medacta shoulder r&d manager: the x-rays confirm mobilization of the glenoid reverse construct towards the anterior direction.The picture of the baseplate shows residuals of hydroxyapatatite but no bone residuals.Given the information at hand it is not possible to identify the reason of the event.
Event or Problem Description
Revision surgery of the glenoid components due to bone fracture and mobilization, the patient has a poor bone quality.Primary performed on (b)(6) 2021.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25
• Common Device Name: SHOULDER BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12480570
• Report Number: 3005180920-2021-00739
• Device Sequence Number: 4346417
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 09/16/2021

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: Health Professional
• Device Expiration Date: 10/04/2025
• Device Model Number: 04.01.0152
• Device Catalogue Number: 04.01.0152
• Device Lot Number: 2006949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/16/2021
• 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: Required Intervention
• Patient Age: 61 YR