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

Model Number	04.01.0090
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00749
• Device Sequence Number: 6576198
• Product Code: KWS
• UDI-Device Identifier: 07630040713139
• UDI-Public: 07630040713139
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 10/05/2022

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: 02/25/2026
• Device Model Number: 04.01.0090
• Device Catalogue Number: 04.01.0090
• Device Lot Number: 2004011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White