MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM STD SIZE 10; CEMENTLESS STEM

Model Number	01.36.050
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 4 months after the primary, the patient came in reporting pain due to a subsided stem and a fractured femur.The surgeon revised the head and stem and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 december 2021.Lot 2100579: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: STEM: SMS SOLID STEM STD SIZE 10
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13306974
• Report Number: 3005180920-2022-00026
• Device Sequence Number: 5070676
• Product Code: LZO
• UDI-Device Identifier: 07630030888694
• UDI-Public: 07630030888694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

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: 04/26/2026
• Device Model Number: 01.36.050
• Device Catalogue Number: 01.36.050
• Device Lot Number: 2100579
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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: Male