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

Model Number 01.12.021

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06 april 2022: lot 152958: (b)(4) items manufactured and released on 07-oct-2015.Expiration date: 2020-09-12.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2018.Clinical evaluation performed by medacta medical director: about 7 years after primary cementless tha in an elderly lady, extensive radiolucent lines are visible on the radiogrphic control around the stem.In absence of a silent infection, this is probably a case of aseptic loosening, a possible adverse event following tha, described in literature.Causes remain often undetermined.We see no discernible clues that could point to a specific cause for this adverse event.

Event Description

Revision surgery following stem loosening 6 years and 5 months after primary.The stem, liner, and head were revised.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Type of Device: HIP 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: 14303478
• MDR Text Key: 291942677
• Report Number: 3005180920-2022-00328
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2020
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 152958
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• 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: 87 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White