MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2; CEMENTLESS STEM

Model Number 01.12.032

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 february 2021: lot 132672: (b)(4) items manufactured and released on 28-aug-2013.Expiration date: 2018-07-31.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 since 2017.Clinical evaluation performed by medical affairs manager: femoral component (stem, head and liner) revision performed 7 years after primary cementless total hip arthroplasty.No information concerning patient age, 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.Preliminary investigation performed by r&d project manager: analyzing the explanted stem images it is visible that almost the whole ha coating has been absorbed by the patient bone as expected.Some signs of scratches are present on the neck surface but is reasonably possible that they are a created during the revision surgery.Looking at the explanted liner is visible a hole on its surface, probably due to the revision surgery.It is not possible to hypothesize a defined root cause.

Event Description

Revision surgery performed 7 years and 2 months after the primary surgery due to aseptic loosening of the stem.The stem and ball head were revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Type of Device: CEMENTLESS 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: 11473643
• MDR Text Key: 239721321
• Report Number: 3005180920-2021-00195
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/12/2021

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: 07/31/2018
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 132672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2013
• 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