MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.18.413
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 19 may 2020: lot 182543: (b)(4) items manufactured and released on 18-sep-2018.Expiration date: 2023-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar reported event.Clinical evaluation performed by medical affairs manager: femoral fracture occurred few days after cementless total hip arthroplasty.According to the report, this event was due to a suboptimal implant position.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
The patient came in 9 days after the primary surgery reporting pain due to a femoral fracture due to the stem being in varus.The stem was oversized and malpositioned.The surgeon revised the stem and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10366324
• Report Number: 3005180920-2020-00518
• Device Sequence Number: 2345180
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 09/04/2023
• Device Catalogue Number: 01.18.413
• Device Lot Number: 182543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/05/2020
• 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