MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE 02.18.004LM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM

Model Number	02.18.004LM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2025.Lot 2404225: (b)(4) items manufactured and released on 24-apr-2024.Expiration date: 2029-apr-10.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs director: at about 8 months after primary cemented uka the femoral component gets loose and needs replacement to a total knee.There is no post-primary xray available, so no comparison can be performed.On the pre-revision xray, detachment of the metal femoral component is evident, but we do not have enough information to attempt an analysis of the causes.Aseptic loosening of cemented metal devices is a possible adverse event widely described in literature, and the causes remain often undetermined.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.
Event or Problem Description
Revision for moto anatomic cemented femur loosening at 7 months from primary.Gmk spherika was implanted successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d department: revision surgery was performed approximately 7 months after the primary uka due to loosening of the moto femoral component.Upon examination of the explanted femoral component, inhomogeneous residual cement was observed on the entire inner surface of the implant and on the pegs in contact with the bone, showing good implant/cement interdigitation and a morphology consistent with interdigitation into cancellous bone.The presence of cement on the internal surface of the implant indicates that there was no lack of integration between the cement and the implant.Cementation issues are generally multifactorial and are more likely related to surgical technique and patient-specific factors, rather than to the implant itself.Moreover, the explanted moto tibial tray and moto tibial insert were available for visual inspection.On the tibial tray, inhomogeneous residual cement was observed on the underside surface of the implant, again showing good implant/cement interdigitation and a morphology consistent with interdigitation into cancellous bone.The tibial insert showed normal signs of wear and some indentations on the anterior lip, probably caused by the removal operation.Based on the visual inspection, there is no indication that the event was caused by a defective or non-compliant device.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO PARTIAL KNEE 02.18.004LM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 LM
• 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: 22269600
• Report Number: 3005180920-2025-00547
• Device Sequence Number: 19795913
• Product Code: HSX
• UDI-Device Identifier: 07630030895593
• UDI-Public: 07630030895593
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 07/17/2025

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: 02.18.004LM
• Device Lot Number: 2404225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: 75 YR
• Patient Sex: Male