MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM COLLARED

Model Number	01.18.232
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2021: lot 2010540: (b)(4) items manufactured and released on 03-feb-2021.Expiration date: 2026-01-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager.Few weeks after cementless total hip arthroplasty, the patient reported pain due to a periprosthetic femoral fracture.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
Periprosthetic fracture 2 weeks after surgery.The surgeon cabled the fracture and revised the stem and head.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM COLLARED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11946671
• Report Number: 3005180920-2021-00473
• Device Sequence Number: 13783275
• Product Code: LZO
• UDI-Device Identifier: 07630030804571
• UDI-Public: 07630030804571
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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: 01/27/2026
• Device Model Number: 01.18.232
• Device Catalogue Number: 01.18.232
• Device Lot Number: 2010540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 70