MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD STEM SIZE 0; UNCEMENTED HIP STEM

Catalog Number	01.18.400
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: revision surgery due to a early postoperative fracture occurred few weeks after primary total hip arthroplasty in an elderly lady ((b)(6)).The fracture probably happened during rehabilitation period when a sudden movement on a weakened bone due to normal femoral preparation, or the presence of a subclinical intraoperative bone fissure may favour the occurrence of this event.
Event or Problem Description
Bone fracture that caused a subsidence of the stem.The surgeon cabled the fracture and revised the stem 1 month and a half after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P STD STEM SIZE 0
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9304130
• Report Number: 3005180920-2019-00954
• Device Sequence Number: 10879601
• Product Code: LZO
• UDI-Device Identifier: 07630040719995
• UDI-Public: 07630040719995
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/11/2019

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 Catalogue Number: 01.18.400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/11/2019
• 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
• Patient Age: 81 YR