MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5; UNCEMENTED HIP STEM

Catalog Number	01.18.405
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 may 2019: lot 179938: (b)(4) items manufactured and released on 15-may-2018.Expiration date: 2023-05-02.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.Clinical evaluation performed by medacta medical manager: five months after cementless total hip arthroplasty, the patient reported pain due to a femoral fracture occurred few days after surgery.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
On the (b)(6) 2019 we were informed of a revision surgery planned for and performed on the (b)(6) 2019, 5 months form the primary, due to pain caused by a fractured femur and subsided stem.The patient getting out of bed heard a popping sound, she assumed it was her knee popping but it was her hip fracturing and the stem subsiding (the patient is overweight).The surgeon revised the ceramic head to extend the patient's leg length and the surgery was completed successfully.The fracture was already healed so the surgeon chose to leave the stem in place.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8595282
• Report Number: 3005180920-2019-00361
• Device Sequence Number: 16686773
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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: 05/02/2023
• Device Catalogue Number: 01.18.405
• Device Lot Number: 179938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/09/2019
• 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