MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.12.004
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 june 2018.Lot 176740: 30 items manufactured and released on 13 december 2017.Expiration date: 2022-11-21.No anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on (b)(6) 2018.Postoperative femoral fracture few days after surgery in a (b)(6) woman.The fracture may have occurred during walking rehabilitation period.The causes of this event may include the initial slightly valgus position of the stem but other conditions such as bone quality or the normal bone weakening due to femoral preparation may have contributed.
Event or Problem Description
Revision surgery due to femoral fracture 10 days after primary.During the revision surgery, surgeon easily explanted the femoral stem and fixed the femoral fracture using 4 bone cerclages and implanted a wagner type stem.Surgeon left the cup (mpact dm) in place and changed femoral head and dm liner with new ones.

• Brand Name: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7605410
• Report Number: 3005180920-2018-00426
• Device Sequence Number: 11111859
• Product Code: JDI
• UDI-Device Identifier: 07630030801853
• UDI-Public: 07630030801853
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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: 11/21/2022
• Device Catalogue Number: 01.12.004
• Device Lot Number: 176740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/15/2018
• 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: 65 YR
• Patient Weight: 70