MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

Model Number	04.01.0122
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month from primary, the patient came in reporting pain due to a dislocation.The cause of the dislocation is unknown.The surgeon revised the poly and upsized to a +3mm liner.The surgery was completed successfully.It should be noted that the coupling of grs baseplate full wedge with a lateralized glenosphere is not registered for use in the usa.
Additional Manufacturer Narrative
Batch review performed on 27-jun-2025: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot.2417035 lot 2417035: (b)(4) items manufactured and released on 26-09-2024 expiration date: 2029-09-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Additional device involved batch review performed on 27-jun-2025 reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot.2421930 lot 2421930: (b)(4) items manufactured and released on 02-12-2024 expiration date: 2029-11-18.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.Clinical evaluation performed by medical affairs department: a revision was performed one month after the primary reverse shoulder arthroplasty (rsa) due to a dislocation.Such events are commonly associated with insufficient restoration of soft tissue tension following the initial procedure.In this case, the surgeon coupled a grs baseplate full wedge with a lateralized glenosphere, which is a coupling not registered for use in the us, probably because he perceived that there was insufficiency of soft tissue efficacy.He attempted to lateralize the implant to increase soft tissue tension, but probably this was not enough.Based on the available information, no further conclusions can be drawn.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
• 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: 22506926
• Report Number: 3005180920-2025-00657
• Device Sequence Number: 15764679
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 04.01.0122
• Device Lot Number: 2417035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown