MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM LAT SIZE 9; CEMENTLESS STEM

Model Number	01.36.069
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient felt a crack two weeks after the primary hip surgery, but was seen by the knee replacement surgeon (the patient is bilateral and also has a tka; on the same side of the broken stem), who did not proceed with further investigations.The patient then continued walking for another two weeks before presenting to the primary hip surgery surgeon.About 1 month and 1 week after the primary surgery, the patient was revised due to stem neck breakage and ceramic liner breakage.
Additional Manufacturer Narrative
Batch review performed on 27 june 2023 lot 2117879:, (b)(4) items manufactured and released on 03-may-2022.Expiration date: 2027-apr-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: a few weeks after primary cementless coc tha, the ceramic insert fractured, and, according to the report, the patient did not report immediately to the operating hip surgeon and kept walking for two additional weeks.After this time, the neck of the stem also broke and removal of all components was mandatory.It appears as a very plausible succession of events that the ceramic insert did not reach the proper final seating at index surgery, which is a known cause for fracture, and after the fracture of the insert, the ceramic fragments acted as cutting tools on the neck of the stem.It is a rather unusual pattern because one would expect that, after the fracture of the insert, the patient is immediately hospitalized and surgery executed.Additional item involved in the event, batch review performed on 27 june 2023: liner: mectacer 01.29.414 ceramic liner ø 36 / f lot.2115407 (the item is not registered in us) lot 2115407: (b)(4) items manufactured and released on 14-feb-2022.Expiration date:2027-feb-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
Manufacturing process review performed by ceramic liner supplier on 20 september 2023 (the item is not marketed in the usa): the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.Due to the fact that the insert at issue was not provided, ceramtec could not carry out any further investigations.

• Brand Name: STEM: SMS SOLID STEM LAT SIZE 9
• Common Device Name: CEMENTLESS STEM
• 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: 17349876
• Report Number: 3005180920-2023-00532
• Device Sequence Number: 20140362
• Product Code: LZO
• UDI-Device Identifier: 07630030888816
• UDI-Public: 07630030888816
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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 Model Number: 01.36.069
• Device Catalogue Number: 01.36.069
• Device Lot Number: 2117879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 95 KG