MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERIKA CEMENTED S4+R

Model Number	02.12.KA14R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment at about 6 months from the medacta primary surgery and the surgeon observed that an implant is failing.Several infections reported during the recovery.There is no other information available at this time.Primary surgery of competitors.A revision has not been scheduled at this time.Medwatch (mw5166553) report was submitted to fda by the patient.Description reported in the fda report: recently had a second total knee revision on (b)(6) 2024 the recovery has been several infections only to find out (b)(6) 2025 by orthopedic doctor the part is failing (part name medecta.).
Additional Manufacturer Narrative
Batch review performed on 06 march 2025: lot 2337255: (b)(4) items manufactured and released on 31-jan-2024.Expiration date: 2029-01-16.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 implants involved, batch review performed on 06 march 2025: gmk-spherika 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 2346162: (b)(4) items manufactured and released on 09-april-2024.Expiration date: 2029-03-26.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.Gmk-spherika 02.12.E0410fr tibial insert fixed sphere flex size 4/10 mm r e-cross (k202022) lot 2402551: (b)(4) items manufactured and released on 12-march-2024.Expiration date: 2029-02-21.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.Gmk-spherika 02.12.E003rp patella resurfacing size 3 e-cross (k202022) lot 2400500: (b)(4) items manufactured and released on 13-march-2024.Expiration date: 2029-02-27.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.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.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERIKA CEMENTED S4+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: 21594484
• Report Number: 3005180920-2025-00215
• Device Sequence Number: 20952105
• Product Code: JWH
• UDI-Device Identifier: 07630345716248
• UDI-Public: 07630345716248
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/13/2025

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.KA14R
• Device Lot Number: 2337255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American