MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK; GMK-SPHERIKA PATELLA RESURFACING SIZE 3 E-CROSS

Model Number	02.12.E003RP
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2025: gmk-spherika 02.12.E003rp patella resurfacing # 3 e-cross (k202022), lot.2425467: (b)(4) items manufactured and released on 15-oct-2024.Expiration date: 29- sept-2029.No anomalies were 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 revised devices batch review performed on 24 july 2025: gmk-spherika 02.12.E0411fl gmk-sphere tibial insert e-cross - flex 4l - 11mm (k202022), lot.2428505: (b)(4) items manufactured and released on 25-nov-2024.Expiration date: 06-nov-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.Gmk-spherika 02.12.Ka04l gmk spherika femoral component s4l cemented (k211004), lot.2432489: (b)(4) items manufactured and released on 07-feb-2025.Expiration date: 22-jan-2030.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.T3i4l tibial tray fixed cemented # t3i4 l (k121416), lot.2431745: (b)(4) items manufactured and released on 24 feb-2025.Expiration date: 06 -feb- 2030.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.Conclusions: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any 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
At about 2 months from the primary surgery, the patient came in due to signs of an infection, and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Fu1: additional information received.Event description (b5) updated.The patient underwent removal of the antibiotic spacers on (b)(6) 2025, followed by implantation of the permanent hardware.The surgery was completed successfully.
Event or Problem Description
At about 2 months from the primary surgery, the patient came in due to signs of an infection, and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The patient underwent removal of the antibiotic spacers on (b)(6) 2025, followed by implantation of the permanent hardware the surgery was completed successfully.

• Brand Name: GMK
• Common Device Name: GMK-SPHERIKA PATELLA RESURFACING SIZE 3 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: 22664405
• Report Number: 3005180920-2025-00738
• Device Sequence Number: 17072822
• Product Code: JWH
• UDI-Device Identifier: 07630971260993
• UDI-Public: 07630971260993
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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.E003RP
• Device Lot Number: 2425467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: 82 YR
• Patient Sex: Female