MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERIKA CEMENTLESS; GMK-SPHERIKA GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S1+L

Model Number	02.12.KA171L
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 january 2025: lot 2408332: (b)(4) items manufactured and released on 19/07/2024.Expiration date: 04/07/2029.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 devices revised: batch reviews performed on 23 january 2025: gmk-spherika 02.12.E0112fl gmk-sphere tibial insert e-cross - flex 1l - 12mm (k202022) lot 2102423: (b)(4) items manufactured and released on 05/05/2021.Expiration date: 20/04/2026.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.Gmk-spherika 02.12.3d01l gmk 3dmetal tibial tray size 1l (k221850) lot 2311627: (b)(4) items manufactured and released on 04/10/2023.Expiration date: 12/09/2028.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.Root cause: the root cause of the observed event is patient's ligament looseness, as reported by the surgeon.The reason for ligament degeneration is unknown but there is no indication that any potential issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient came in reporting pain due to a dislocation of the femur from the tibial insert due to ligament looseness.About 7 days after the primary surgery, the surgeon revised all components and the surgery was completed successfully.The patient's revision surgery included revising the femur, tibia, and tibial insert components and gmk revision components were then implanted and a semi-constrained insert was used.No traumatic event was reported.

• Brand Name: GMK SPHERIKA CEMENTLESS
• Common Device Name: GMK-SPHERIKA GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S1+L
• 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: 21227337
• Report Number: 3005180920-2024-01173
• Device Sequence Number: 7559739
• Product Code: MBH
• UDI-Device Identifier: 07630345799289
• UDI-Public: 07630345799289
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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.KA171L
• Device Lot Number: 2408332
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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: 37 YR
• Patient Sex: Female