MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ24.5; REVERSE SHOULDER GLENOSPHERE

Model Number	04.01.0178
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs departement on 07 may 2020: lot 179968: (b)(4) items manufactured and released on 18-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 with 2 other similar events reported.Additional implant involved: reverse shoulder system 04.01.0117 humeral reverse hc liner ø32/+3mm (k170452) lot.179976.Batch review performed by medacta regulatory affairs departement on 07 may 2020: 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 events reported.
Event or Problem Description
The patient came in, 4 months after primary surgery, reporting pain due to a dislocation of the humerous from the glenosphere; the cause of the dislocation is unknown.The surgeon revised the glenosphere, metaphysis, diaphysis and liner, and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 32XØ24.5
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10091188
• Report Number: 3005180920-2020-00293
• Device Sequence Number: 3407015
• Product Code: PHX
• UDI-Device Identifier: 07630040708135
• UDI-Public: 07630040708135
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2023
• Device Model Number: 04.01.0178
• Device Catalogue Number: 04.01.0178
• Device Lot Number: 179968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• 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