MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 32XØ24.5; REVERSE SHOULDER GLENOSPHERE

Catalog Number	04.01.0206
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 months after the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the glenosphere and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 09 january 2024.Lot 2117710: (b)(4) manufactured and released on 22-march-2022.Expiration date: 2027-03-07.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional component involved in the complaint: batch review performed on 09 january 2024 reverse shoulder system 04.01.0116 humeral reverse hc liner ø32/+0mm (k170452) lot 2203294: (b)(4) manufactured and released on 21-apr-2022.Expiration date: 2027-03-31.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 32XØ24.5
• Common Device Name: REVERSE SHOULDER GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18493518
• Report Number: 3005180920-2023-01096
• Device Sequence Number: 7187956
• Product Code: HSD
• UDI-Device Identifier: 07630040728058
• UDI-Public: 07630040728058
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/11/2024

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 Catalogue Number: 04.01.0206
• Device Lot Number: 2117710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2023
• Initial Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White