MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 2, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.02SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 1810070: (b)(4) items manufactured and released on (b)(6) 2019.Expiration date: 2023-12-19.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
Per-operative femur fracture discovered with x-ray control.The stem and femoral head have been revised intraoperatively.The surgery was completed successfully.

• Brand Name: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 2, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8915169
• Report Number: 3005180920-2019-00694
• Device Sequence Number: 13937602
• Product Code: JDI
• UDI-Device Identifier: 07630030802119
• UDI-Public: 07630030802119
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072857
• 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): 08/21/2019

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: 12/19/2023
• Device Catalogue Number: 01.12.02SN
• Device Lot Number: 1810070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/21/2019
• 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: 70 YR
• Patient Weight: 90