MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-9

Model Number	04.01.0026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 years 10 months after the primary, the patient came in presenting persistent pain and the cause is unknown.There were no indications of trauma or bone quality issues.The surgeon revised the anatomical shoulder to a reverse shoulder system, leaving the diaphysis implanted from the primary surgery.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 29 april 2026 anatomical shoulder system 04.01.0026 humeral anatomical metaphysis-cementless-135 & deg: -9 lot.(k170910) lot: 1905776: (b)(4) items manufactured and released on 28-nov-2019.Expiration date: 2024-11-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Anatomical shoulder system 04.01.0093 metal humeral head d 46 (k170910) lot: 1905793: (b)(4) items manufactured and released on 16-oct-2019.Expiration date: 2024-10-01.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.Anatomical shoulder system 04.01.0131 hc pegged glenoid d 46 (k170910) lot: 182675: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-17.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.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot: 1905791: (b)(4) items manufactured and released on 22-oct-2019.Expiration date: 2024-10-07.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 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: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-9
• 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: 25148957
• Report Number: 3005180920-2026-00448
• Device Sequence Number: 13445097
• Product Code: KWS
• UDI-Device Identifier: 07630040712644
• UDI-Public: 07630040712644
• Combination Product (Y/N): N
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/12/2026

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 Expiration Date: 11/18/2024
• Device Model Number: 04.01.0026
• Device Lot Number: 1905776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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: 63 YR
• Patient Sex: Male