MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

Model Number	02.12.0410FR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 april 2025.(b)(4) items manufactured and released on 02-april-2024.Expiration date: 2029-03-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional devices involved: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.2337017 (b)(4) items manufactured and released on 22-jan-2024.Expiration date: 2029-01-02.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation performed by clinical affairs department a few months after primary tkr, the polyethylene insert is found dissociated from the tray.This has happened while the patient was in bed.According to the surgeon, the insert had been correctly implanted at index surgery.Insert dissociation is a very rare occurrence, and in most cases the cause is incomplete clipping during primary surgery.This situation may be determined by visual inspection of the dissociated insert, which is not available in this case.It must be noted that the replacement insert chosen was significantly thicker than the original one, suggesting that a lack of stability (possibly secondary) was found.Also, the anterior configuration of this patient's knee seems to include potential extensor system deficiencies, but of course this is not a cause for dissociation of the insert - it is however a potential cause for reduced stability of the joint.With no explant to examine, no further conclusion can be drawn.Root cause: although it is not possible to confirm a certain root cause, it is likely that the unique challenges of the surgical application resulted in an impediment to fully securing the insert with the possibility that the insert was not fully clipped into the intended position.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
Revision surgery for liner dissociation at 3 months from primary.Liner successfully revised (10 to 14 mm).

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R
• 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: 21975205
• Report Number: 3005180920-2025-00378
• Device Sequence Number: 17948762
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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 Model Number: 02.12.0410FR
• Device Lot Number: 2404049
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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