MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3; CEMENTLESS HIP STEM

Model Number 01.12.033

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2020: lot 161558: 40 items manufactured and released on 20-may-2016.Expiration date: 2021-05-09.No anomalies found related to the problem.To date, 37 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed on (b)(6) 2020 by medacta r&d hip project manager: from the received images it is not possible to determine the root cause of the event.It may be possible the presence of radiolucencies around the stem in the x-ray image, while the explanted stem did not show any particular sign.A more detailed analysis can be done with the physical piece.Clinical evaluation performed by medical affairs manager: femoral component revision performed 4 years after primary cementless total hip arthroplasty in (b)(6) year old man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.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.

Event Description

Revision surgery 4 years and 3 months after primary for stem loosening.Quadra h replaced with quadra c.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11129987
• MDR Text Key: 231242410
• Report Number: 3005180920-2021-00019
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 161558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR