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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-mar-2025: lot 2312760: (b)(4) items manufactured and released on 05-12-2023.Expiration date: 2028-11-19.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.Additonal devices involved batch review performed on 14-mar-2025: reverse shoulder system 04.01.0004 standard humeral diaphysis s9 (k170910) lot 2207913: (b)(4) items manufactured and released on 22-06-2022.Expiration date: 2027-05-26.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 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2346718: (b)(4) items manufactured and released on 26-01-2024.Expiration date: 2029-01-10.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 04.01.0161 glenoid polyaxial locking screw - l30 lot.2347371 (k170452) lot 2347371: (b)(4) items manufactured and released on 31-01-2024.Expiration date: 2029-01-13.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 04.01.0111 humeral reverse metaphysis +9mm/0° (k170452) lot 2003393: (b)(4) items manufactured and released on 21-10-2020.Expiration date: 2025-10-08.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 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 1909888: (b)(4) items manufactured and released on 17-02-2020.Expiration date: 2025-02-05.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) lot 2318878: (b)(4) items manufactured and released on 15-02-2024.Expiration date: 2029-01-30.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 04.01.0211 lat.Glenosphere 39xø27 (k193175) lot 2336629: (b)(4) items manufactured and released on 22-01-2024.Expiration date: 2029-01-01.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 medacta medical affairs manager: revision surgery 1 year after the previous operation, reportedly due to metal allergy and suspected infection but there is no mention of clinical conditions.This is a second revision, the first one was due to infection.From the radiographic images it is not possible to evaluate this condition.These are known possible adverse events.The reported cause was metal allergy with no alleged device deficiency or contributing factor, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
On (b)(6)2023 patient undergone reverse shoulder arthroplasty.On the (b)(6)2024 surgeon revised al components due to infection (mdr 3005180920-2024-00151).On (b)(6) 2025 all components were revised for metal allergy along with a suspicion of infection (metal allergy).No loosening of the components.Surgeon implanted competitor ipoallergenic device and surgery was completed successfully.

• 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: 21736862
• Report Number: 3005180920-2025-00262
• Device Sequence Number: 4108979
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: 2312760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 93 KG