MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PFJ SYSTEM; MOTO PATELLA E-CROSS Ø29

Model Number	02.15.E029
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 may 2026 gmk-revision 02.15.E029 moto patella e-cross d 29 (k213071) lot: 2421817: (b)(4) items manufactured and released on 11-sept-2024.Expiration date: 2029-sept-02.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-revision 02.07.0412scf fixed tibial insert semiconstrained s.4 / 12 mm (k103170) lot: 2116747: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-dec-12.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: the surgeon revised liner height, which is a common practice to restore joint stability, and revised the patella implant.Based on the information available, no definitive root cause can be established, while there is no indication that any potential issue with the devices may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
At 1 year and 2 months from primary, the patient came in presenting anterior knee pain over the patella knee joint and the cause is unknown.The patient complained of the patella getting caught in ps femur notch.Laxity and scar tissue was observed.There are no indications of trauma.The surgeon revised the moto d 29 patella to a moto d 38 patella and revised the semiconstrained 12mm insert to an insert p.S.14mm s4.The surgery was completed successfully.

• Brand Name: MOTO PFJ SYSTEM
• Common Device Name: MOTO PATELLA E-CROSS Ø29
• 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: 25313933
• Report Number: 3005180920-2026-00538
• Device Sequence Number: 13397313
• Product Code: HSX
• UDI-Device Identifier: 07630971262522
• UDI-Public: 07630971262522
• Combination Product (Y/N): N
• PMA/510(K) Number: K213071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/28/2026

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.E029
• Device Lot Number: 2421817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: Black Or African American