MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 22X15

Model Number	04.01.0148
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 october 2021.Lot 2012464: 30 items manufactured and released on 20-apr-2021.Expiration date: 2026-04-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation: few days after primary rsa the joint dislocates and the glenoid bone is found fracture at ct scan.It was not possible to determine if the condition had been determined by trauma, because the patient is demented and cannot confirm.The mobilized baseplate was removed and the reverse prosthesis changed to anatomic, with no glenoidal implant.No reason to suspect a device deficiency at the origin of this problem.Other devices involved: batch review performed on 04 october 2021: reverse shoulder system 04.01.0117 humeral reverse hc liner ¿32/+3mm (k170452)lot 179976: (b)(4) items manufactured and released on 24-apr-2018.Expiration date: 2023-04-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Reverse shoulder system 04.01.0167 glenosphere 32x¿22 (k170452) lot 189859a: (b)(4) items manufactured and released on 28-jan-2021.Expiration date: 2026-01-17.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any similar reported event.Lot 189859a derives from lot 189859: lot 189859: (b)(4) items manufactured and released on 10-apr-2019.Expiration date: 2024-03-10.No anomalies found related to the problem.To date, no items of the same lot have been sold.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452)lot.2010930: lot 2010930: (b)(4) items manufactured and released on 12-jan-2021.Expiration date: 2025-12-29.No anomalies found related to the problem.To date, 57 items of the same lot have been already sold without a similar reported event.Note that two devices with the same lot number were reported in this case.
Event or Problem Description
Revision surgery was performed due to dislocation.The primary surgery was performed on (b)(6) 2021 and revision surgery was performed on (b)(6) 2021.Due to suspicion of hematoma, the surgeon took a ct scan and noticed an abnormality in the glenoid fossa.During the course of revision surgery, the surgeon noticed glenoid fracture and dislocation of the base plate.Glenoid implants were all removed.The humeral liner and tray were replaced with an anatomical head.The surgery was completed successfully.The patient has dementia, it is unknown if there was a traumatic event.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 22X15
• Common Device Name: GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12597642
• Report Number: 3005180920-2021-00796
• Device Sequence Number: 4201005
• Product Code: PHX
• UDI-Device Identifier: 07630040706353
• UDI-Public: 07630040706353
• 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
• 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): 10/08/2021

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: 04/06/2026
• Device Model Number: 04.01.0148
• Device Catalogue Number: 04.01.0148
• Device Lot Number: 2012464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/08/2021
• 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: 77 YR
• Patient Weight: 60