MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SMS SOLID STEM LAT SIZE 10; HIP STEM

Catalog Number 01.36.070

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02-aug-2023.Lot 2100584: (b)(4) items manufactured and released on 20-apr-2021.Expiration date: 2026-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department: revision 5 days post primary cementless total hip arthroplasty, due to a periprosthetic fracture.It is unknown if a traumatic event occurred.However, weakening of the bone during surgical femoral preparation is a known possible complication of tha.This may favour the occurrence of early fracture during rehabilitation.From the radiographic images, it is visible that a quadra p was implanted and the bone was cabled to fix the fracture.There is no reason to suspect a faulty device.

Event Description

Revision due to periprosthetic bone femoral fracture, at about 5 days post primary.It is unknown if a traumatic event occurred.A quadra stem has been implanted.

• Brand Name: SMS SOLID STEM LAT SIZE 10
• Type of Device: HIP 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: 17594766
• MDR Text Key: 321630104
• Report Number: 3005180920-2023-00645
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030888823
• UDI-Public: 07630030888823
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K181693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.36.070
• Device Lot Number: 2100584
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White