MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø40; SHOULDER METAL HUMERAL HEAD

Model Number 04.01.0090

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19 september 2022: lot 2004011: 12 items manufactured and released on 11-mar-2021.Expiration date: 2026-02-25.No anomalies found related to the problem.Since release to date, 5 items of the same lot have been sold with no similar reported event in the period of review.

Event Description

The surgeon operated again the patient to change the head orientation in an anatomical hemi prosthesis shoulder.Head and double eccenter revised successfully.A head of the same size was implanted but with a different orientation.

• Brand Name: ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø40
• Type of Device: SHOULDER METAL 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15542035
• MDR Text Key: 301154229
• Report Number: 3005180920-2022-00749
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07630040713139
• UDI-Public: 07630040713139
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0090
• Device Catalogue Number: 04.01.0090
• Device Lot Number: 2004011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White