MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERE SIZE 2+ R TINBN COATED

Model Number	02.12.0722R
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18-jul-2025: lot: 2416851: (b)(4) items manufactured and released on 14-10-2024 expiration date: 2029-09-29.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 device involved, batch review performed on 18-jul-2025: gmk efficiency 77.11.1052 sphere trial femur s2+ r lot: mat76610: (b)(4) items manufactured and released on 17-12-2024.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.
Event or Problem Description
During tka the efficiency trial femoral component was used to tiral the femur and drill the holes for the femoral implant pegs.Afterward, when trying to insert the final implant the surgeon noticed that the pegs of the implants were not aligned with the holes.The mismatch was in the anterior direction of approximatively 5mm.Surgeon removed the implant, redrilled the holes and refined the bone cuts.The patient bone had to be recemented again and finally implant was positioned.A total of 20 minutes of delay over 45 minutes of surgery was reported.
Additional Manufacturer Narrative
Visual inspection performed by r&d department.During the visual inspection of the part subject to the complaint, no discrepancies were found either in terms of dimensions or shape.Since these parts are manufactured through molding, they are not subject to dimensional variations that could justify what is reported in the event description.Furthermore, as they are produced in large quantities per batch and we have not received any other malfunction reports, we can exclude a defect related to production.It cannot be ruled out that the problem may occurred due to inaccurate femoral resections, where the femoral efficiency trials, not accounting for press-fit in the internal profile, may have adapted to a position slightly different from the final implant; however, even in this case, the declared difference of about 5 mm remains unexplained.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.The trial component does not present discrepancies in terms of dimensions or shape, therefore the geometric design is not a factor in the issue reported.

• Brand Name: GMK TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT SPHERE SIZE 2+ R TINBN COATED
• 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: 22737764
• Report Number: 3005180920-2025-00740
• Device Sequence Number: 7188935
• Product Code: JWH
• UDI-Device Identifier: 07630040711531
• UDI-Public: 07630040711531
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.12.0722R
• Device Lot Number: 2416851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian