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

Model Number 04.01.0093

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 march 2023: lot 1903164: (b)(4) manufactured and released on 30-july-2019.Expiration date: 2024-07-21.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional devices involved batch reviews performed on 20 march 2023: anatomical shoulder system 04.01.0089 double eccenter (k170910) lot 1903973: (b)(4) manufactured and released on 18-sep-2019.Expiration date: 2024-09-03.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Anatomical shoulder system 04.01.0029 humeral anatomical metaphysis - cementless - 135° - 12 (k170910) lot 1811030: (b)(4) manufactured and released on 21-feb-2019.Expiration date: 2024-02-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Anatomical shoulder system 04.01.0133 hc pegged glenoid ø50 (k170910) lot 184441: (b)(4) manufactured and released on 04-feb-2019.Expiration date: 2024-01-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

Event Description

At about 3 years 1 month after the primary, the patient came in reporting pain due to a torn rotator cuff and the cause is unknown.The surgeon converted the patient from anatomic to reverse and the surgery was completed successfully.

• Brand Name: ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø46
• Type of Device: SHOULDER HUMERAL 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: 16723117
• MDR Text Key: 313110828
• Report Number: 3005180920-2023-00237
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0093
• Device Catalogue Number: 04.01.0093
• Device Lot Number: 1903164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2023
• 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 Sex: Male