MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46; SHOULDER METAL HEAD

Catalog Number	04.01.0093
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year and 1 month from the primary, the patient came in reporting pain due to not being able to have full arm rotation.Range of motion was limited and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14 september 2023: lot 1903164: 20 items manufactured and released on 30-jul-2019.Expiration date: 2024-07-21.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved batch review performed on 14 september 2023: anatomical shoulder system 04.01.0004 std humeral diaphysis - cementless - 9 (k170452) lot 2012131: 26 items manufactured and released on 01-feb-2021.Expiration date: 2026-01-19.No anomalies found related to the problem.To date, 25 items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0026 humeral anatomical metaphysis - cementless - 135° - 9 (k170910) lot 1811227: 49 items manufactured and released on 21-feb-2019.Expiration date: 2024-02-11.No anomalies found related to the problem.To date, 43 items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0130 hc pegged glenoid ø44 (k170910) lot 2103247: 26 items manufactured and released on 30-apr-2021.Expiration date: 2026-04-15.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 2003985: 117 items manufactured and released on 19-jan-2021.Expiration date: 2025-12-28.No anomalies found related to the problem.To date, 105 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46
• Common Device Name: SHOULDER METAL HEAD
• 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: 17868939
• Report Number: 3005180920-2023-00781
• Device Sequence Number: 20321880
• Product Code: KWS
• UDI-Device Identifier: 07630040713160
• UDI-Public: 07630040713160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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: 07/21/2024
• Device Catalogue Number: 04.01.0093
• Device Lot Number: 1903164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2019
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 118 KG