MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

Model Number	01.12.025
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 19 may 2020: lot 1900008: (b)(4) items manufactured and released on 29-apr-2019.Expiration date: 14.04.2024.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.
Event or Problem Description
The patient dislocated in the hospital and after further investigation with x-ray it was discovered subsidence of the femoral component, the surgeon suspects that during the primary surgery 8 days before occurred a bone fracture, but it is not confirmed if the fracture occurred during of after the primary surgery.The surgeon revised the stem and head and cabled the fracture.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Common Device Name: CEMENTLESS, HA COATED STD STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10147233
• Report Number: 3005180920-2020-00326
• Device Sequence Number: 2420625
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 04/14/2024
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 1900008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/12/2020
• 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
• Patient Age: 71 YR