MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2; HIP AMISTEM-P COLLARED STD STEM

Catalog Number 01.18.432

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 10/25/2023

Event Type  Injury  

Event Description

The patient had pain due to a subsided stem and the cause of the subsided stem is unknown.At about 13 days from primary the surgeon revised the stem and head and the surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 30 october 2023: lot 2302647: 40 items manufactured and released on 24-may-2023.Expiration date: 2028-05-03.No anomalies found related to the problem.To date, 30 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2
• Type of Device: HIP AMISTEM-P COLLARED STD 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: 18204617
• MDR Text Key: 328911119
• Report Number: 3005180920-2023-00901
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630040720212
• UDI-Public: 07630040720212
• 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: 11/24/2023

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: 01.18.432
• Device Lot Number: 2302647
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/24/2023
• 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: Female