MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE5/10 MM R; FIXED TIBIAL INSERT

Catalog Number 02.12.0510FR

Device Problem Material Discolored (1170)

Patient Problem Joint Disorder (2373)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 january 2018.Lot 163076: (b)(4) items manufactured and released on 04 august 2016.Expiration date: 2021-07-25.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.Visual inspection performed on 09 january 2018 by (b)(4) joint director: on the lateral side of the articular surface (low congruency zone), i can easily recognise the milling manufacturing pattern on the pe surface.This is a clear sign that there are no pe wear on this side.On the medial side of the articular surface (high congruency zone), i can see a zone where i can easily recognise the milling pattern on the pe surface and a zone that has been polished by the contact with the femoral component.The polished zone has no sign of delamination and no evident sign of wear.The spherical shape of the medial side appears to be unalterated.The integrity of the entire liner is well defined.Some zones of the liner are yellowed.This color change represents a lipid absorption by the liner.Metrological analysis performed by quality control manager 11 january 2018: based on the lot documentation, no anomaly was found.The whole dossier of the manufacturer is conforming to the project specifications.Dimensional control, has not identified any anomaly or defect.The device is conforming.

Event Description

The patient came in complaining of patella pain.The surgeon revised the poly and resurfaced the patella.The surgeon noticed that the explanted insert had oxidized (little bit yellow).The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE5/10 MM R
• Type of Device: FIXED TIBIAL INSERT
• 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: 7185278
• MDR Text Key: 97058995
• Report Number: 3005180920-2017-00831
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826740
• UDI-Public: 07630030826740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.12.0510FR
• Device Lot Number: 163076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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): Required Intervention