MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P 01.18.465 AMISTEM- P SHORT NECK STD STEM SIZE 5; HIP FEMORAL STEM

Catalog Number 01.18.465

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 march 2024 lot 2236293: 20 items manufactured and released on 25-jan-2023.Expiration date: 2028-01-09.No anomalies found related to the problem.To date, 8 items of the same lot have been sold without any similar reported event during the period of review.

Event Description

Femoral bone fracture discovered at one week from the primary.The surgeon is considering wire fixation or changing to cement stem.

• Brand Name: STEM: AMISTEM P 01.18.465 AMISTEM- P SHORT NECK STD STEM SIZE 5
• Type of Device: HIP FEMORAL 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: 18942040
• MDR Text Key: 338142773
• Report Number: 3005180920-2024-00107
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630971243699
• UDI-Public: 07630971243699
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192126
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.18.465
• Device Lot Number: 2236293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian