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

Catalog Number	01.12.20SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 august 2018.Lot 174411: (b)(4) items manufactured and released on 05 december 2017.Expiration date: 2022-11-26 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.Clinical evaluation performed by medical affairs manager on 24 august 2018.Postoperative femoral fracture, 2 weeks after primary cementless tha in a (b)(6) woman.The fracture may have occurred during walking re-education period of time when sudden movements on a weakened bone due to the normal intraoperative femoral preparation may cause such event.No reason to suspect that this event is due to a faulty device.
Event or Problem Description
The surgeon used anterior off table approach.The surgeon removed the quadra stem along with the ceramic head due to femur fracture occurred 2 weeks after primary.The stem was removed easily.The fracture was cabled and the surgeon cemented in a size 0, 44 offset xacta stem with a 36 -4 ceramic head.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7837107
• Report Number: 3005180920-2018-00650
• Device Sequence Number: 16437984
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 11/26/2022
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 174411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/31/2018
• 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: 66 YR