MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/13 MM RIGHT

Catalog Number	02.12.0213FR
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 september 2017.Lot 152447: (b)(4) items manufactured and released on 29 october 2015.Expiration date: 2020-10-13.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.On 20 september 2017 the r&d project manager performed a preliminary investigation based on the event description and on the pictures of the explanted uhmwpe insert, and commented as follows: revision due to pain and reduced knee flexion 7 months post primary.Femoral lift off on medial side at about 90* flexion.It is not possible to identify any possible root cause for the event that is potentially implant related.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.
Event or Problem Description
Knee revision due to pain and reduced knee flexion 7 months after primary rtkr.Femoral lift off on medial side at about 90° flexion.Upon removal of 13mm poly insert there appeared to be yellow markings on insert suggesting oxidisation of polyethylene insert.Likely poor flexion post-op due to not enough posterior slope applied to tibia.Rom improved with scar releases and tissue releases.Poly insert downsized to 12mm.
Additional Manufacturer Narrative
Patient match department review of the case: each step of the myknee process has been reviewed and no errors have been found.As no x-ray was provided, it was not possible to perform any further analysis.Our analysis of the process of this case found no deviations from the standard procedures.Each step has been performed correctly.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/13 MM RIGHT
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6886396
• Report Number: 3005180920-2017-00530
• Device Sequence Number: 706564
• Product Code: JWH
• UDI-Device Identifier: 07630030862557
• UDI-Public: 07630030862557
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2020
• Device Catalogue Number: 02.12.0213FR
• Device Lot Number: 152447
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 65