MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H 01.12.032 CEMENTLESS, HA COATED LAT STEM SIZE 2; FEMORAL COMPONENT

Model Number 01.12.032

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 28 september 2021: lot 164553: (b)(4) items manufactured and released on 8-11-2016.Expiration date: 2021-10-17 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event since 2017.Visual inspection performed by r&d manager: looking at the images it is visible the explanted stem was covered with patient blood.It is not easy to identify if the ha coating has been absorbed completely by patient bone, even if it seems so.Some signs and scratches are present on the stem neck due to revision surgery.More details will be added during visual inspection if the stem will be available.The root cause remains unknown.

Event Description

Revision surgery was performed about 4 years after the primary surgery due to stem mobilization.The exact primary date is unknown.

• Brand Name: QUADRA-H 01.12.032 CEMENTLESS, HA COATED LAT STEM SIZE 2
• Type of Device: FEMORAL COMPONENT
• 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: 12711292
• MDR Text Key: 278814043
• Report Number: 3005180920-2021-00828
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 164553
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2016
• 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): Other
• Patient Age: 59 YR