MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED STD STEM SIZE 4; HIP CEMENTLESS STEM

Catalog Number 01.18.434

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 feb 2024: lot 2301312: (b)(4) items manufactured and released on 24-may-2023.Expiration date: 2028-05-01.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.

Event Description

After the primary hip surgery, in post-op recovery, the patient sustained a distal bone fracture.The same day of the primary, the surgeon cabled the fracture, revised the medacta stem with a competitor stem and the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: AMISTEM-P COLLARED STD STEM SIZE 4
• Type of Device: 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: 18957391
• MDR Text Key: 338303161
• Report Number: 3005180920-2024-00132
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720236
• UDI-Public: 07630040720236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.434
• Device Lot Number: 2301312
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2023
• 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 Weight: 91 KG
• Patient Race: White