MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PFJ SYSTEM; MOTO PATELLA E-CROSS Ø32

Model Number	02.15.E032
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 weeks from the primary a revision surgery was performed due to infection.Methicillin-resistant staphylococcus aureus (mrsa) was already present preoperatively.
Additional Manufacturer Narrative
Batch review performed on 25 may 2026 gmk-sphere 02.15.E032 moto patella e-cross d 32 (k213071) lot 2531536: (b)(4) items manufactured and released on 03-feb-2026.Expiration date: 19-jan-2031.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-sphere 02.12.Ka04r gmk spherika femoral component s4r cemented (k211004) lot 2533839: (b)(4) items manufactured and released on 09-mar-2026.Expiration date: 19-feb-2031.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-sphere 02.12.E0410fr gmk-sphere tibial insert e-cross - flex 4r - 10mm (k202022) lot 2525060: (b)(4) items manufactured and released on 09-oct-2025.Expiration date: 24-sep-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-sphere 02.07.1204r tibial tray fix cemented s.4r (k090988) lot 2529110: (b)(4) items manufactured and released on 05-feb-2026.Expiration date: 14-jan-2031.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: 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: MOTO PFJ SYSTEM
• Common Device Name: MOTO PATELLA E-CROSS Ø32
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25442538
• Report Number: 3005180920-2026-00548
• Device Sequence Number: 20265266
• Product Code: HSX
• UDI-Device Identifier: 07630971262539
• UDI-Public: 07630971262539
• Combination Product (Y/N): N
• PMA/510(K) Number: K213071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 02.15.E032
• Device Lot Number: 2531536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2026
• 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: 74 YR
• Patient Sex: Male