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

Catalog Number	01.18.404
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2020.Lot 182528: 100 items manufactured and released on 07-sep-2018.Expiration date: 2023-08-23.No anomalies found related to the problem.To date, 97 items of the same lot have been already sold without any similar reported even.
Event or Problem Description
Revision surgery performed 1 year and 8 months after primary surgery, due to a broken femur.Stem, ball head and bipolar head have been successfully revised.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs department: postoperative femoral fracture, one year and 8 months after primary cementless tha.The fracture is due to a traumatic event.No reason to suspect that this event is due to a faulty device.

• Brand Name: STEM: AMISTEM P STD STEM SIZE 4
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11093712
• Report Number: 3005180920-2020-00962
• Device Sequence Number: 676303
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 08/23/2023
• Device Catalogue Number: 01.18.404
• Device Lot Number: 182528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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: 89 YR
• Patient Weight: 75