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

Catalog Number 04.01.0093

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/11/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324896241
• Report Number: 3005180920-2023-00781
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07630040713160
• UDI-Public: 07630040713160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0093
• Device Lot Number: 1903164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 118 KG