MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R E-CROSS; KNEE TIBIAL INSERT

Catalog Number	02.12.E0612FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed due to dissociation of the e-cross inlay from the tibial baseplate 1 year after the primary surgery.The inlay has been revised.
Additional Manufacturer Narrative
Batch review performed on 21-mar-2024 lot 2110600: (b)(4) items manufactured and released on 30-sep-2021.Expiration date: 2026-09-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation performed by r&d project manager: preliminary investigation based on the picture of the removed components reveals that the distal surface of the component looks damaged, presenting sort of incisions of the negative shape of the tibial baseplate; these have been most likely caused by the edges of the lateral profile of the baseplate when the insert underwent to bodyload pressure and was not engaged in the tibial tray.It is likely that the insert was not proprely engaged during primary surgery.There is no evidence to suspect that the event was related to a faulty device.Clinical evaluation performed by medical affairs director: one year after primary cemented tka with a medially stabilized system, the patient feels instability and the surgeon reopens the joint.Apparently he found a stable implant and replaced the insert only, adding 1mm thickness.From the photograph of the explanted insert, it appears rather likely that the insert dissociated from the tray, or that it never reached full clipping-in.As no radiographs were supplied, we cannot formulate an opinion on the position of the devices.It is to be presumed that during revision surgery an adjustment of the soft tissues was performed, but we have no data.No final conclusion can be reached with the information at hand.Additional item involved in the event, batch review performed on 21-mar-2024 gmk-sphere 02.07.1206r tibial tray fixed cemented size 5 l (k090988) lot.2119408 lot 2119408: (b)(4) items manufactured and released on 19-may-2022.Expiration date: 2027-05-04.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Additional Manufacturer Narrative
After have sent the initial report on march 21st 2024 it was recognised that the date of the event was incorrect.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM R E-CROSS
• 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: 18951463
• Report Number: 3005180920-2024-00114
• Device Sequence Number: 7348814
• Product Code: JWH
• UDI-Device Identifier: 07630971262324
• UDI-Public: 07630971262324
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/21/2024

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: 09/14/2026
• Device Catalogue Number: 02.12.E0612FR
• Device Lot Number: 2110600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown