MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; KNEE TIBIAL INSERT

Model Number	02.12.0210FR
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Fibrosis (3167); Joint Laxity (4526)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to knee instability at 5 years and 5 months from medacta primary.Fibrous tissue observed and suspected to be due to wear.Poly upsized (from 10 to 13 mm) and patella resurfaced.
Additional Manufacturer Narrative
Batch review performed on 30 sept 2024.Lot 179683: (b)(4) items manufactured and released on 22-mar-2018.Expiration date: 2023-03-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager: revision surgery of a gmk sphere insert after 5 years after primary surgery due to instability; during revision, a thicker insert was applied.From visual inspection of the removed component sent for investigation, we can't see any signs of tibio-femoral contact on the lateral side, as if the insert was not loaded by the femur.The medial spherical articular surface seems to be regularly worn out after years of implantation, with the surface almost polished.We can note also a sort of deformation of the medial edge on the insert, like if the femur was also putting pressure on this edge.From analysis of the explanted components, we guess that the event is related to an improper tensioning of the collateral ligaments, with a tight mcl and a relaxed lcl.Some yellow discoloration is visible, which is normally due to lipid absorption - it is not an indicator of wear.From visual inspection, there is no evidence that the event is related to a faulty device.Clinical evaluation performed by medical affairs department 5 years after revision tka (revision of uka) the patient develops instability and a thicker insert is applied.We understand that femoral and tibial metal components have been left in place because well performing and fixed.During the operation, resurfacing of the patella is also performed - it had not been done previously.Secondary instability is a rather common development following tka, mainly due to secondary relaxation of the collateral ligaments, and a thicker insert normally can solve the problem.The pictures of the removed insert show that on the lateral side the machining marks are still visible, which is rather unusual after 5 years and may indicate that the lateral compartment was not loaded.Instead, the medial compartment does show signs of polishing, probably because it was carrying the load by itself.It may have worn more than usual because of this and it's possible that some fibrous tissue has developed to separate the polyethylene debris - this is normal reaction.It does not appear that the wear on the medial compartment was abnormal or that it may have contributed decisively to the revision.Some yellow discoloration is visible, which is normally due to lipid absorption - it is not an indicator of wear.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE TIBIAL INSERT
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20522210
• Report Number: 3005180920-2024-00861
• Device Sequence Number: 12758326
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 03/12/2023
• Device Model Number: 02.12.0210FR
• Device Lot Number: 179683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White