MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7; CEMENTLESS HIP STEM

Model Number	01.12.027
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2021: lot 170876: (b)(4) items manufactured and released on 12-jul-2017.Expiration date: 2022-07-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by medacta r&d hip project manager: looking at the image attached to the complaint is visible that the ha coating as been absorbed by the patient bone as expected.Indeed the surgery was 4 hours long to remove the stem to the bone, meaning that it was very well osterointegrated.A scratch is visible on the stem tip probably caused during the revision surgery.It is not possible to determine the root cause of the radiolucency lines caused of this complaint.Clinical evaluation performed by medacta medical affairs director: hip revision surgery performed 2 years and 7 months after cementless total hip arthroplasty in a young man ((b)(6) year old).Radiographic image shows the presence of minimal radiolucent lines in gruen zone 1, no pain was reported.In some cases, minimal radiolucencies are seen after cementless total hip arthroplasty but this finding alone may not be related to implant loosening.It is a surgeon choice to remove the implant.During revision surgery, the stem was difficult to remove suggesting that some sort of fixation occurred.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed due to subclinical stem mobilization 2 years and 7 months after the primary surgery.Minimal radiolucent lines were visible on the x-ray.The stem and the cup were revised.There was no problem with the cup, it was revised because the surgeon didn't like the x-ray with the screws which were fixing the cup.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11419746
• Report Number: 3005180920-2021-00174
• Device Sequence Number: 2776221
• Product Code: JDI
• UDI-Device Identifier: 07630030802089
• UDI-Public: 07630030802089
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 07/02/2022
• Device Model Number: 01.12.027
• Device Catalogue Number: 01.12.027
• Device Lot Number: 170876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/05/2021
• 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: 51 YR