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

Catalog Number	01.18.411
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 5 days from the primary, the patient heard a pop and felt pain after attending a physical therapy session during exercises that involved walking up steps.When the surgeon took x-rays, there was no evidence of a fracture but the patient felt pain, so the surgeon decided to revise.During the surgery, the surgeon found the stem a little be loose, so he revised it with a longer one and revised the head too.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 june 2024: lot 2306048: (b)(4) items manufactured and released on 27-jun-2023.Expiration date: 2028-06-11.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.

• Brand Name: AMISTEM P LAT 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: 19642083
• Report Number: 3005180920-2024-00492
• Device Sequence Number: 8673601
• Product Code: LZO
• UDI-Device Identifier: 07630040720106
• UDI-Public: 07630040720106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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 Catalogue Number: 01.18.411
• Device Lot Number: 2306048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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: 59 YR
• Patient Sex: Male