MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1; CEMENTLESS FEMORAL STEM

Model Number 01.12.021

Device Problems Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Inadequate Osseointegration (2646)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18 may 2021: lot 156210: (b)(4) items manufactured and released on 15-june-2016.Expiration date: 2021-01-03.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 since 1-1-2017.

Event Description

The surgeon will revise the patient hip on (b)(6) 2021.The patient has hip pain and a stem loosening is suspected.For the revision planned 4 years and 8 months after primary the surgeon plans to revise all the products.

Event Description

Revision surgery was performed 4 years and 8 months after primary for stem loosening.All implants were revised successfully.The acetabular components swap was a surgeon choice, there were no acetabular problems, but the surgeon revised them to reduce the risk of potential infection due to the surgery.

Manufacturer Narrative

On (b)(6) we were informed that the revision surgery was performed and completed successfully.Clinical evaluation performed by medical affairs director: hip revision surgery performed 4 years and 8 months after primary cementless total hip arthroplasty in a 64 year old man.In the radiographic image provided the stem looks slightly varus and, in the pre-revision situation, undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by r&d project manager: the implant is not clearly visible in the photo attached to the complaint due the fact that it is inside a plastic box.What visible is that the ha coating on the stem body is completely absorbed by patient bone as expected.It is not possible to see if some scratches are present or not.It is not possible to determine the root cause of the reported patient pain.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11938602
• MDR Text Key: 254462693
• Report Number: 3005180920-2021-00468
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (y/n): N
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 156210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 74