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	Osteolysis (2377)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery 4 years and 11 months after the primary surgery due to not medacta baseplate loosening, not medacta screw breakage and osteolysis found in the glenoid part.The surgeon converted the patient to an anatomic shoulder.The surgery was completed successfully.Liner and metaphysis are the only medacta products.
Additional Manufacturer Narrative
Batch review performed on 30 december 2024: lot 173418: (b)(4) items manufactured and released on 2017-07-03.Expiration date: 2022-06-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, no similar reported event during the period of review.Batch review performed on 30 december 2024: reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 1905789: (b)(4) items manufactured and released on 2019-10-31.Expiration date: 2024-10-16.No anomalies found related to the problem.To date, all items of the same lot have been sold, no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: revision surgery done due to breakeage of a screw and the loosening of the glenosphere and the baseplate which are not from medacta.The only part from medacta are the liner and the metaphysis which are not the reason of the revision.Root cause: revision surgery done due to breakeage of a screw and the loosening of the glenosphere and the baseplate which are not from medacta.The only part from medacta are the liner and the metaphysis which are not the reason of the revision.
Additional Manufacturer Narrative
Reason for the follow up.On 24.Oct.2025 the complaint (b)(4) was notified, and we discovered, a few days later with some questions, that the patient was involved in the complaint (b)(4).The patient, revised in 2024, had the second step revision as part of the original treatment plan following the bone graft healing.The surgeon had previously bone grafted the glenoid and was waiting for it to heal before he could perform the reverse shoulder.This is why he converted the patient to reverse.Presently, on (b)(6) 2025, the patient came in reporting pain and the cause is unknown.The surgeon converted the medacta hemiarthroplasty to a reverse shoulder.The surgery was completed successfully.Implanted: 04.01.0119 humeral reverse hc liner ø36/+0mm 2414226 04.01.0110 humeral reverse metaphysis +0mm/0° 2434141.

• 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: 21197089
• Report Number: 3005180920-2024-01179
• Device Sequence Number: 20701931
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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 Expiration Date: 06/18/2022
• Device Model Number: 04.01.0122
• Device Lot Number: 173418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2017
• 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: 79 YR
• Patient Sex: Female