MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/10 MM L

Catalog Number 02.12.0410FL

Device Problems Material Discolored (1170); Unstable (1667)

Patient Problem Joint Disorder (2373)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Visual inspection of the explanted tibial insert performed on (b)(6) 2018 by r&d product manager: tibial insert explanted after 1 month from primary implantation due to infection.Insert is found intact, with no 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.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.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.Batch review performed on 24 may 2018: lot 170297: 50 items manufactured and released on 29 march 2017.Expiration date: 2022-09-03.No anomalies found related to the issue.To date, 41 items of the same lot have been already sold without any similar reported event.

Event Description

Revision surgery due to instability about 1 year after the primary, the tibial insert was replaced by an inlay with an increased thickness.Yellowish discolorations observed on the removed insert.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #4/10 MM L
• Type of Device: TIBIAL INSERT FIXED
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544735
• MDR Text Key: 109265161
• Report Number: 3005180920-2018-00369
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826535
• UDI-Public: 07630030826535
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/25/2018

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 Expiration Date: 09/03/2022
• Device Catalogue Number: 02.12.0410FL
• Device Lot Number: 170297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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 Age: 65 YR