MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø36/+0MM

Model Number	04.01.0119
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Metal Related Pathology (4530)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to nickel allergy after about 1 year and 6 months after primary surgery.The surgeon revised the glenosphere to a sensitin glenosphere and the insert to a same size insert.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14 april 2026 reverse shoulder system 04.01.0119 humeral reverse hc liner d 36/+0mm (k170452) lot.2409939: (b)(4) items manufactured and released on 05-jun-2024.Expiration date: 2029-may-21.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0207 lat.Glenosphere 36xd 24.5 (k193175) lot.2348684: (b)(4) items manufactured and released on 16-apr-2024.Expiration date: 2029-apr-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0301 grs baseplate - d 24.5x20 +3mm (k213459) lot.2308514: (b)(4) items manufactured and released on 24-apr-2024.Expiration date: 2029-apr-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: based on the available information, no definitive root cause can be established.However, the findings are consistent with a local allergic reaction.There is no indication that a device-related issue caused or contributed to the event, and the device history record review did not identify any manufacturing-related issues.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø36/+0MM
• 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: 25077214
• Report Number: 3005180920-2026-00376
• Device Sequence Number: 21519459
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 04.01.0119
• Device Lot Number: 2409939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2024
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female