MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 42X24.5; REVERSE SHOULDER GLENOSPHERE

Model Number	04.01.0171
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2021: lot 183802: (b)(4) items manufactured and released on 13-feb-2019.Expiration date: 2024-01-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar event.Additional implant involved: reverse shoulder system 04.01.0152 glenoid baseplate ø24.5x25 (k170452) lot.184560.Batch review performed on 14 january 2021: lot 184560: (b)(4) items manufactured and released on 2-jul-2019.Expiration date: 2024-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar events.Additional implant involved: reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot.179984.Batch review performed on 14 january 2021: lot 179984: (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 with 1 similar event.Additional implant involved: reverse shoulder system 04.01.0114 humeral reverse metaphysis +0mm/+20°r (k170452) lot.1906619a.Batch review performed on 14 january 2021: lot 1906619a: (b)(4) items manufactured and released on 13-gen-2020.Expiration date: 2024-11-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar events.
Event or Problem Description
The patient came in 1 week after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed washout, removed all implants, applied antibiotic powder, and closed the incision without putting new implants.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 42X24.5
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11278418
• Report Number: 3005180920-2021-00081
• Device Sequence Number: 11781680
• Product Code: PHX
• UDI-Device Identifier: 07630040706582
• UDI-Public: 07630040706582
• 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): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 01/30/2024
• Device Model Number: 04.01.0171
• Device Catalogue Number: 04.01.0171
• Device Lot Number: 183802
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/04/2021
• 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