MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L; FIXED TIBIAL INSERT

Model Number 02.12.0310FL

Device Problems Material Discolored (1170); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 2 october 2020: lot 187212: (b)(4) items manufactured and released on 10-dec-2016.Expiration date: 2023-11-22.No anomalies found related to the problem.To date, 112 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: this is a secondary resurfacing of patella, for disease progression.During surgery, the polyethylene inlay was exchanged, as it is customary to do, but no functional problem had been recorded.The observation that there is yellowish staining on the insert is not an indicator of any problem or defect, it's normal lipidic deposition on pe.Visual inspection performed by (b)(4) project manager: tibial insert explanted after 7 months from primary implantation.Reasons for revision are unknown.Insert is found intact, with no evident signs of usage or wear.Upon removal of the poly insert, yellow markings were found.This turning of the color into yellow in some portions of the uhmwpe components, is something already experienced and deeply analyzed in medacta ( (b)(4) ).This is something that affects only the external surfaces of the insert and not related to abnormal oxidation of the liner.Specific testing to evaluate the oxidation index (oi) has been performed on similar product that "in vivo" turned its colour into yellow ((b)(4)).As results of those studies, the oi index of the explanted liner was comparable with the oi of a liner analyzed after accelerating aging with the exception of the surface.According to the study published by costa et al "analysis of products diffused into uhmwpe prosthetic components in vivo", the apolar components of synovial liquid such as cholesterol, fatty acid, esters of cholesterol and squalene are able to diffuse into uhmwpe.Therefore the reason of the change of the color should be the absorption of lipids from the synovial fluid present in the joint of the patient.

Event Description

Revision surgery 7 months after primary surgery for patella bone resurfacing.The insert was changed for prophylaxis.The revised insert was found to be yellowish.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 10717881
• MDR Text Key: 212496655
• Report Number: 3005180920-2020-00720
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826337
• UDI-Public: 07630030826337
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121416
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2023
• Device Model Number: 02.12.0310FL
• Device Catalogue Number: 02.12.0310FL
• Device Lot Number: 187212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2016
• 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