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

Model Number 01.12.031

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 04 march 2021: lot 072273: (b)(4) items manufactured and released on 18-oct-2007.Expiration date: 2012-09-31.No anomalies found related to the problem.(b)(4) items has been re-sterilized as lot 072273/t and released on 07-nov-2013.Expiration date: 2018-09-31.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.Clinical evaluation: stem revision performed 4 years and 8 months after primary cementless total hip arthroplasty in a (b)(6) year old man.In the radiographic image provided, signs of stress shielding are visible and the stem looks slightly 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: looking at the images of the explanted stem it is visible that almost all ha coating on the stem body has been absorbed by patient bone as expected.There are only a few residual fragments of ha coating on the body.The root cause remains unknown.

Event Description

4 years and 8 months after primary, revision surgery for loose quadra h stem.The surgeon revised successfully the stem and head.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
• 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: 11568315
• MDR Text Key: 242228389
• Report Number: 3005180920-2021-00235
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 01.12.031
• Device Catalogue Number: 01.12.031
• Device Lot Number: 072273/T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2013
• 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
• Patient Age: 71 YR
• Patient Weight: 80