MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-8

Model Number	04.01.0025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 months from the primary surgery, the patient came in reporting pain, and the cause is unknown.The surgeon converted the patient from an anatomic shoulder to a hemi shoulder.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 august 2025 lot.2348667: (b)(4) items manufactured and released on 04-april-2024.Expiration date: 19 march 2029.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.Additional items involved in the event: 04.01.0089 double eccenter (k170910) lot.2418711: (b)(4) items manufactured and released on 03-sept-2024.Expiration date: 28 aug 2029.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.04.01.0090 metal humeral head ø40 (k170910) lot.2343901: (b)(4) items manufactured and released on 02-april-2024.Expiration date: 17 march 2029.No anomalies were 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.Conclusions: 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°-8
• 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: 22883313
• Report Number: 3005180920-2025-00804
• Device Sequence Number: 21233623
• Product Code: KWS
• UDI-Device Identifier: 07630040712637
• UDI-Public: 07630040712637
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• 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): 08/25/2025

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: 04.01.0025
• Device Lot Number: 2348667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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 Sex: Unknown