MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P COLLARED STD STEM SIZE 1; HIP CEMENTLESS STEM

Model Number	01.18.431
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2204061: 20 items manufactured and released on (b)(6) 2022.Expiration date: 2027-06-01.No anomalies found related to the problem.To date, 15 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: about 2 months after the surgery, the patient complained of pain, and when an x-ray was taken, according to report, it was discovered that the stem was subsided.As the lesser trochanter appears to be fractured, we suspect that the integrity of the femur may have been compromised during primary surgery and probably a fracture may have developed in the following weeks.This hypothesis is reinforced by the radiographic image of bone repair process around the lesser trochanter.There is no reason to suspect a faulty device.
Event or Problem Description
About 2 months after the surgery, the patient complained of pain, and when an x-ray was taken, it was discovered that the stem was sinking.The patient is under monitoring and the surgeon is evaluating a revision surgery.

• Brand Name: STEM: AMISTEM P COLLARED STD STEM SIZE 1
• 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: 17030861
• Report Number: 3005180920-2023-00404
• Device Sequence Number: 7012372
• Product Code: LZO
• UDI-Device Identifier: 07630040720205
• UDI-Public: 07630040720205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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 Model Number: 01.18.431
• Device Catalogue Number: 01.18.431
• Device Lot Number: 2204061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian