MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 6; UNCEMENTED HIP STEM

Catalog Number	01.12.006
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 185936: 20 items manufactured and released on 11/08/2018.Expiration date: 10/29/2023.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Total hip prosthesis surgery, a post-op rx control showed a compound fracture at the femoral level.The surgeon cabled the fracture the same day of the primary, no implants have been revised.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 6
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8914344
• Report Number: 3005180920-2019-00693
• Device Sequence Number: 617759
• Product Code: JDI
• UDI-Device Identifier: 07630030801877
• UDI-Public: 07630030801877
• 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
• 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: 10/29/2023
• Device Catalogue Number: 01.12.006
• Device Lot Number: 185936
• 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: 71 YR
• Patient Weight: 70