MAUDE Adverse Event Report: Medacta International SA Shoulder System; Glenosphere - Ø39x27

Model Number	04.01.0173
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After a review of the custom reverse shoulder glenoid following a primary surgery, the surgeon observed some lucency around the screws in the glenoid along with a positive culture test for cutibacterium acnes.The surgeon treated the patient with intravenous antibiotics along with oral antibiotics.The patient`s labs were stable and physical exam were good in a follow-up on (b)(6) 2025.
Additional Manufacturer Narrative
Batch review performed on 27 august 2026 reverse shoulder system 04.01.0173 glenosphere - d 39x27 (k170452) lot 2402694: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 02-may-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.Cm24.256 reconstr.Reverse glenoid lot 2430528: (b)(4) items manufactured and released on 25 november 2024.Expiration date: 18 november 2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: Shoulder System
• Common Device Name: Glenosphere - Ø39x27
• Manufacturer (Section D): Medacta International SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 50692292
• Report Number: 3005180920-2026-00934
• Device Sequence Number: 18563196
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Model Number: 04.01.0173
• Device Lot Number: 2402694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2024
• 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: Other
• Patient Sex: Unknown