MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 32X22

Model Number	04.01.0167
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 february 2021: lot 183536: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-20.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 item involved in the event, batch review performed on 18 february 2021: reverse shoulder system 04.01.0118 humeral reverse hc liner ø32/+6mm (k170452) lot.179977 lot 179977: (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 reported event.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the liner from the glenosphere which was occurred when the patient had a muscle spasm.2 months after primary the surgeon revised the glenosphere, metaphysis, and liner.The surgery was completed successfully.The surgeon revised the metaphysis only to obtain room to access the glenoid for removal.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 32X22
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11451744
• Report Number: 3005180920-2021-00179
• Device Sequence Number: 4049088
• Product Code: PHX
• UDI-Device Identifier: 07630040706544
• UDI-Public: 07630040706544
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

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: 11/20/2023
• Device Model Number: 04.01.0167
• Device Catalogue Number: 04.01.0167
• Device Lot Number: 183536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• 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