MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30

Catalog Number	04.01.0191
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 november 2019: lot 183704: 102 items manufactured and released on 10-sep-2018.Expiration date: 2023-08-29.No anomalies found related to the problem.To date, 77 item of the same lot have been already sold.Additional implants involved in the event, batch review performed on (b)(6) 2019.Reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot.174739 lot 174739: 200 items manufactured and released on 21-dic-2017.Expiration date: 2022-12-10.No anomalies found related to the problem.To date, 125 item of the same lot have been already sold.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot.179970.Lot 179970: 140 items manufactured and released on 17-may-2018.Expiration date: 2023-05-06.No anomalies found related to the problem.To date, 103 item of the same lot have been already sold.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot.184569 (2 pieces).Lot 184569: 303 items manufactured and released on 15-jan-2019.Expiration date: 2023-12-05.No anomalies found related to the problem.To date, 180 item of the same lot have been already sold.Reverse shoulder system 04.01.0171 glenosphere 42xø24.5 (k170452) lot.183802 lot 183802: 139 items manufactured and released on 13-feb-2019.Expiration date: 2024-01-30.No anomalies found related to the problem.To date, 7 item of the same lot have been already sold.Reverse shoulder system 04.01.0006 std humeral diaphysis - cementless - 11 (k170452) lot.178132.Lot 178132: 70 items manufactured and released on 29-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, 46 item of the same lot have been already sold.Reverse shoulder system 04.01.0126 humeral reverse hc liner ø42/+3mm (k170452) lot.189838 lot 189838: 52 items manufactured and released on 25-jan-2019.Expiration date: 2024-01-13.No anomalies found related to the problem.To date, 17 item of the same lot have been already sold.
Event or Problem Description
Revision surgery performed after 3 months from the primary due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
• Common Device Name: THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9375797
• Report Number: 3005180920-2019-01008
• Device Sequence Number: 2258125
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 08/29/2023
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 183704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/26/2019
• 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