MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.12.023

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

On 27 october 2017, the manufacturer of the ceramic component involved in the complaint (not marketed in us) provided a document review, reporting as follows: the component properties and the microstructure as obtained from the quality documents accomplish the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilization.Due to lack of ceramic parts further investigations cannot be done.Batch reviews performed on 30 october 2017.(b)(4).To date, all items of the same lot have been already sold without any similar reported event.

Event Description

Stem loosening due to infection.The revision will be done on (b)(6) 2017.

Manufacturer Narrative

Revision performed: the stem removed and the surgery went on successfully.Implants are not available for investigation.The stem was completely loose and easy to remove.On the implant was no osseointegration.The surgeon supposes a loosening due to infection, but as long as he didn't get the results, we cannot confirm anything.Clinical investigation (b)(6) by medical affairs director: late infection in cementless tha, 2 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD
• Type of Device: CEMENTLESS FEMORAL 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, 6874 ; SZ 6874
• MDR Report Key: 6990398
• MDR Text Key: 90674039
• Report Number: 3005180920-2017-00634
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Catalogue Number: 01.12.023
• Device Lot Number: 153553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2017
• 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 Weight: 102