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
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00107
• Device Sequence Number: 8232110
• Product Code: LZO
• UDI-Device Identifier: 07630971243699
• UDI-Public: 07630971243699
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/20/2024

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: 01.18.465
• Device Lot Number: 2236293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian