MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA GENERAL CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; CEMENTLESS STEM

Catalog Number	01.12.23SN
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 december 2017 lot 166563: (b)(4) items manufactured and released on 09 february 2017.Expiration date: 2022-02-01 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
Patient had primary surgery on (b)(6) 2017.During insertion and impaction of the definitive implant (size 1 quadrah sn (b)(4)) with the ceramic head, the surgeon noted that the implant had sunk in by approximately 15mm.He continued to broach up and settled on a number 3 broach.A size 3 quadrah sn (b)(4) was opened and inserted.Xray was called and surgeon was satisfied with result.Patient was closed as per normal protocols.On (b)(6) 2017 it was noted that there was a fracture of the femur and a revision was planned for (b)(6) 2017 this surgery was completed on (b)(6) 2017 where able were passed around the femur to stabilize the fracture.

• Brand Name: QUADRA GENERAL CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7147258
• Report Number: 3005180920-2017-00784
• Device Sequence Number: 1109763
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2017

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: 02/01/2022
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 166563
• 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: 11/29/2017
• Initial Report FDA Received Date: 12/27/2017
• 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: 43 YR
• Patient Weight: 55