MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 32X24.5; REVERSE SHOULDER GLENOSPHERE

Model Number	04.01.0178
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 may 2021: lot 183799: (b)(4) items manufactured and released on 02-may-2019.Expiration date: 2024-04-16.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.Additional implant involved: reverse shoulder system 04.01.0116 humeral reverse hc liner ø32/+0mm (k170452) lot.179975.Batch review performed on 11 may 2021: lot 179975: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-19.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.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the liner from the glenosphere 3 days after primary surgery.The cause of the dislocation is unknown.The surgeon revised the liner implanting a different size and the surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 32X24.5
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11876627
• Report Number: 3005180920-2021-00442
• Device Sequence Number: 3633570
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 04/16/2024
• Device Model Number: 04.01.0178
• Device Catalogue Number: 04.01.0178
• Device Lot Number: 183799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/25/2021
• 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