MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+6MM

Catalog Number	04.01.0118
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2019: lot 173416: (b)(4) items manufactured and released on 27-june-2017.Expiration date: 2022-06-08.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event additional implant involved in the event, batch review performed on 17 july 2019: reverse shoulder system 04.01.0178 glenosphere 32xø24.5 (k170452) lot.179968 lot 179968: (b)(4) items manufactured and released on 18-april-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 other similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a dislocation of the liner from glenosphere.The cause of the dislocation is unknown.The surgeon closed reduced the patient 1 month and a half after primary and no implants were revised.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø32/+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: 8841032
• Report Number: 3005180920-2019-00655
• Device Sequence Number: 259738
• Product Code: PHX
• UDI-Device Identifier: 07630040706254
• UDI-Public: 07630040706254
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 06/08/2022
• Device Catalogue Number: 04.01.0118
• Device Lot Number: 173416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/30/2019
• 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