MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R; TIBIAL KNEE INSERT FIXED

Model Number 02.12.0210FR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 may 2023.Lot: 1909427: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-nov-23.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.Additional item involved in the event, batch review performed on 15 may 2023.Gmk-sphere 02.12.0702r femoral component sphere tinbn coated size 2 r (k202684) lot: 174170 lot: 174170: (b)(4) items manufactured and released on 11-oct-2017.Expiration date: 2022-oct-01.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.Preliminary investigation performed by r&d knee manager: revision surgery of a gmk sphere implant after almost 2 years from primary implantation due to instability.The liner was replaced with a thicker one but the surgeon will revise all the system to pass to an hinge in august this year, due to medial instability.During the revision surgery it was noted that the coating on the sensitin femoral component was 'rubbed off in one point'.Despite this damage, the patient and the other implanted components don't have any problems.From the picture of the implant sent for investigation, we can notice a stripe on the distal medial condyle where the coating is no more present.The defect seems to have a very defined and regular shape and looks different from scratches expected in case of detachment caused by a third body.No further considerations can be done just looking at the picture sent.

Event Description

About 1 year and 10 months after the primary surgery, the liner was revised with a thicker one (from 10 to 12mm) due to instability.During the revision, the tinbn-coating of the femoral component was found rubbed off in one condyle.No material was found between the femur and the insert.The femoral component was not revised.The surgeon plans to revise the patient to switch to a hinge system because the instability persists.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• Type of Device: TIBIAL KNEE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17077576
• MDR Text Key: 316678644
• Report Number: 3005180920-2023-00417
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.0210FR
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 1909427
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2019
• 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