MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12; REVERSE SHOULDER HUMERAL DIAPHYSIS CEMENTLESS

Catalog Number	04.01.0185
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10.August.2021.Lot 172590: (b)(4) items manufactured and released on 15-may-2017.Expiration date: 2022-may-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implants involved: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.184049.Lot 184049: (b)(4) items manufactured and released on 3-jan-2019.Expiration date: 2023-dec-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.175043.Lot 175043: (b)(4) items manufactured and released on 19-sep-2017.Expiration date: 2022-sep-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 (k170452) lot.175029.Lot 175029: (b)(4) items manufactured and released on 20-dec-2017.Expiration date: 2022-nov-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot.179109.Lot 179109: (b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-mar-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot.183687.Lot 183687: (b)(4) items manufactured and released on 19-sep-2018.Expiration date: 2023-sep-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot.174281.Lot 174281: (b)(4) items manufactured and released on 13-nov-2017.Expiration date: 2022-nov-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event (it did not lead to a revision surgery).
Event or Problem Description
2 years and 2 months after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 12
• Common Device Name: REVERSE SHOULDER HUMERAL DIAPHYSIS CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12427665
• Report Number: 3005180920-2021-00707
• Device Sequence Number: 19660305
• Product Code: PHX
• UDI-Device Identifier: 07630040715935
• UDI-Public: 07630040715935
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/06/2021

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: 05/04/2022
• Device Catalogue Number: 04.01.0185
• Device Lot Number: 172590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/06/2021
• 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