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

Catalog Number 01.12.022

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/28/2023

Event Type  Injury  

Event Description

At about 7 years and 8 months after primary, the patient has been revised because of stem loosening.The surgery has been completed successfully.

Manufacturer Narrative

Batch review performed on 07 december 2023 lot 155089: (b)(4) items manufactured and released on 16-dec-2015.Expiration date: 2020-dec-02.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager.Looking at the stem body an opaque white film is visible on approximately 2/3 of the stem length, located in the proximal part of it.It is not possible to identify if this film is ha or bone residual, or a combined effect.Not absorption of ha from the stem body can indicate that no metabolic activity was taking place and that, presumably, no correct bone contact was achieved.The fact that the opaque white film is not present in the distal part only is something unexpected.In fact the stem has been primary implanted in 2016 (7 years of implantation).On the basis of one published in vivo study (soballe et al 1996, the current status of hydroxyapatite coating of prostheses, the journal of bone and joint surgery) it is demonstrated that the around 80% of ha on implants is absorbed by patient bone within 1 year.The post-op x-ray analysis and patient informations (gender, age, bone status.) could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding but unfortunatly they are not available at the moment.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18372070
• MDR Text Key: 331094968
• Report Number: 3005180920-2023-01040
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Catalogue Number: 01.12.022
• Device Lot Number: 155089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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