MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; HIP CEMENTLESS STEM

Model Number	01.12.20SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 1905425: 50 items manufactured and released on 08-oct-2019.Expiration date: 2024-09-24.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Primary surgery performed successfully in the morning.In the afternoon the surgeon noticed that the patient was in pain and legg was shorter than the other suddenly.He took a ct where the stem was subsided and it showed a peri prosthetic fracture, subsidence happened after causing the fracture.Patient has a very osteoporotic bone quality.Revision surgery performed 7 days after primary.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10697594
• Report Number: 3005180920-2020-00724
• Device Sequence Number: 14414234
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• Combination Product (Y/N): Y
• Initial Reporter Country: BE
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 10/19/2020

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: 09/24/2024
• Device Model Number: 01.12.20SN
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 1905425
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/19/2020
• 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: 73 YR