MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14; CEMENTED HIP STEM

Catalog Number	01.12.043
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 174061: 46 items manufactured and released on 04 august 2017.Expiration date: 2022-07-24.No anomalies found related to the problem.To date, 39 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on (b)(6) 2018.Femoral fracture occurred in an infected hip few days after revision surgery due to previous infection.The fracture may be the consequence of femoral bone preparation on an unhealthy femoral bone.There is no reason to suspect a faulty device.
Event or Problem Description
The patient initially had a competitor stem and cup implanted which was revised for infection.The surgeon implanted a quarda c stem and versacem/dm construct in as a 1st stage revision (b)(6) 2018.The infection remained active and the patient had a post operative femoral fracture.The patient was booked for another surgery to remove components and repair fracture.Fracture was not repaired due to patient bleeding uncontrollably.Patient transferred to another hospital.
Additional Manufacturer Narrative
On 03 dec 2018 it was communicated that the last revision surgery has been performed.A quadra c implant with versacem cup and dual mobility liner was used.On 19 dec 2018 it was indicated that the date of the last revision surgery was (b)(6) 2018.

• Brand Name: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7929613
• Report Number: 3005180920-2018-00744
• Device Sequence Number: 1346884
• Product Code: LZO
• UDI-Device Identifier: 07630030802249
• UDI-Public: 07630030802249
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083558
• 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,Followup
• Report Date (Section B): 01/02/2019

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: 07/24/2022
• Device Catalogue Number: 01.12.043
• Device Lot Number: 174061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: 78 YR
• Patient Weight: 100