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

Catalog Number	01.18.404
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 october 2019: lot 179936: 160 items manufactured and released on 04-may-2018.Expiration date: 2023-04-25.No anomalies found related to the problem.To date, 140 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: femoral fracture occurred few days after cementless total hip arthroplasty in a 71 year old woman.During rehabilitation period, weight bearing or a sudden movement on a weakened bone due to normal femoral preparation or the presence of subclinical fissure may favour the occurrence of early fractures.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed after 6 days from the primary due to stem subsidence caused by a femur fracture.Primary surgery: the surgeon revised all implants and placed a strapping on the femur.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9304031
• Report Number: 3005180920-2019-00953
• Device Sequence Number: 390433
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• 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: 2018
• Device Explanted Year: 2018
• 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 Expiration Date: 04/25/2023
• Device Catalogue Number: 01.18.404
• Device Lot Number: 179936
• 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: 71 YR