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

Model Number	04.01.0093
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00237
• Device Sequence Number: 15251489
• 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: 2020
• 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): 04/12/2023

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 Model Number: 04.01.0093
• 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: 03/13/2023
• Initial Report FDA Received Date: 04/12/2023
• 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 Sex: Male