MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERE PATELLA RESURFACING SIZE 2 E-CROSS

Model Number	02.12.E002RP
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 march 2025.Lot: 2409781: (b)(4) items manufactured and released on 13-june-2024.Expiration date: 2029-05-27.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 implant revised.Batch review performed on 10 march 2025 on gmk-sphere 02.12.E0417fr tibial insert fixed sphere flex size 4/17 mm r e-cross (k202022) lot.2102431.Lot: 2102431: (b)(4) items manufactured and released on 05-may-2021.Expiration date: 2026-04-22.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.The surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 2 months after the primary, the patient came in reporting pain due to a dislocated patella implant and knee instability.The surgeon revised the 17mm poly with a 20mm poly and performed a lateral release and vmo advancement.The surgery was completed successfully.

• Brand Name: GMK
• Common Device Name: GMK-SPHERE PATELLA RESURFACING SIZE 2 E-CROSS
• 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: 21687575
• Report Number: 3005180920-2025-00249
• Device Sequence Number: 9420165
• Product Code: JWH
• UDI-Device Identifier: 07630971260986
• UDI-Public: 07630971260986
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• 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): 03/25/2025

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.E002RP
• Device Lot Number: 2409781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Race: Black Or African American