MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS SOLID COLLARED STEM LAT SIZE 13; HIP CEMENTLESS STEM

Catalog Number	01.36.173
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	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 november 2023 lot 2307700: (b)(4) items manufactured and released on 24-march-2023.Expiration date: 2028-03-19.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs manager: a revision surgery was conducted 3 months after the first implant of tha using a sms collared uncemented stem.We do not have information about the clinical status of the patient, who was significantly overweight.The reported cause of the revision was stem subsidence and this is confirmed by the available x-ray images, which also showed that it occured after just one month.This may be caused by the lack of primary stability, probably due to an undersizing of the final implant, with overweight as an additional risk factor.We do not have reason to suspect a faulty or defective device.
Event or Problem Description
Revision surgery due to sms collared solid stem subsidence, at about 3 months and half after primary.Stem and head successfully revised.Patient's bone quality good.

• Brand Name: SMS SOLID COLLARED STEM LAT SIZE 13
• Common Device Name: HIP 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: 18266625
• Report Number: 3005180920-2023-00964
• Device Sequence Number: 12735316
• Product Code: LZO
• UDI-Device Identifier: 07630345701954
• UDI-Public: 07630345701954
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/05/2023

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 Catalogue Number: 01.36.173
• Device Lot Number: 2209163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 113 KG