MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0170
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	04/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 27 may 2020: lot 183537: (b)(4) items manufactured and released on 15-oct-2018.Expiration date: 2023-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Additional device involved: batch review performed by medacta regulatory affairs department on 27 may 2020: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 184048: (b)(4) items manufactured and released on 26-jun-2018.Expiration date: 2023-06-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported events.Clinical evaluation performed by medacta medical affairs director: partial revision of rsa 1 year after primary surgery.According to report the patient fell and the trauma caused dislocation of the glenosphere from the baseplate and damage to the pe insert.The relationship between trauma and separation of glenosphere from baseplate is uncertain, but experience on the specific is very limited and a firm conclusion cannot be drawn.Most likely, the traumatic event is responsible for the failure.
Event or Problem Description
The patient came in reporting pain due to a fall 1 year after the primary surgery.The liner is worn, the glenosphere dissociated from the baseplate and the screw unscrewed.The surgeon revised the glenosphere, liner, metaphysis and left the baseplate in place as it was well fixed, and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10091539
• Report Number: 3005180920-2020-00299
• Device Sequence Number: 14304526
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 183537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• 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: Required Intervention