MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P 01.18.464 AMISTEM- P SHORT NECK STD STEM SIZE 4; HIP STEM

Model Number	01.18.464
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 july 2021: lot 2002212: (b)(4) items manufactured and released on 28-jul-2020.Expiration date: 2025-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Oblique bone fracture around the tip of the femoral stem was reported.The patient was hospitalized.No revision is planned at the moment.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: few weeks after cementless total hip arthroplasty, the patient reported pain due to a fracture in the calcar region.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
Event or Problem Description
Oblique bone fracture around the tip of the femoral stem was reported.The patient was hospitalized.No revision is planned at the moment.
Event or Problem Description
Oblique bone fracture around the tip of the femoral stem was reported.The fracture led to stem subsidence.The subsidence was observed about 2-3 weeks after the primary surgery.The bone was fixed with a plate.No implants were revised.Additional surgery date is unknown.

• Brand Name: STEM: AMISTEM P 01.18.464 AMISTEM- P SHORT NECK STD STEM SIZE 4
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12352936
• Report Number: 3005180920-2021-00662
• Device Sequence Number: 3887443
• Product Code: LZO
• UDI-Device Identifier: 07630971243682
• UDI-Public: 07630971243682
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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 Expiration Date: 07/17/2025
• Device Model Number: 01.18.464
• Device Catalogue Number: 01.18.464
• Device Lot Number: 2002212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 07/20/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/22/2021; 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2020
• 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: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian