MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+6MM

Model Number	04.01.0124
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 november 2020: lot 1910100: (b)(4) items manufactured and released on 07-may-2020.Expiration date: 2025-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Clinical evaluation: early dislocation of a revision rsa few weeks after surgery.According to the report, excessive activity during rehabilitation was the main cause for this problem.At open reduction, metaphysis and insert were replaced to seek a more stable joint configuration.No reason to suspect faulty implants.Other device involved in the event: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm lot.179981 (k170452) batch review performed on 30 november 2020: lot 179981: (b)(4) items manufactured and released on 24-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 already sold without any similar reported.
Event or Problem Description
Revision surgery performed 2 months after the primary surgery due to dislocation of the prosthesis.The surgeon revised the metaphysis and the insert.The event was caused due to the patient was too active in physiotherapy and everyday life.The medacta shoulder was implanted to replace a competitor system in a very complicated surgery.The broken screw visible on the x-ray is a part of competitor's prosthesis previously explanted.
Additional Manufacturer Narrative
On 01-feb-2021 we received information about correct patient's weight and age.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER 39/+6MM
• Common Device Name: HUMERAL REVERSE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11019542
• Report Number: 3005180920-2020-00909
• Device Sequence Number: 3822900
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 04/28/2025
• Device Model Number: 04.01.0124
• Device Catalogue Number: 04.01.0124
• Device Lot Number: 179981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/03/2021
• 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: 60 YR
• Patient Weight: 80