MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM; KNEE FEMORAL COMPONENT

Model Number	02.18.003RM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-mar-2023: lot 2212250: (b)(4) items manufactured and released on 13-sep-2022.Expiration date: 2027-08-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affair director: shortly after primary uka, the patient's tibial bone gave way and transition to a tkr was required.The surgeon commented that this patient had very soft bone; we understand that the surgeon probably offered to the patient the option of trying the less invasive partial replacement but the outcome proved immediately not good enough.There is no reason to suspect a faulty device at the origin of this failure.Investigation performed by medacta knee r&d manager: revision surgery of a moto medial implant after one month from primary most likely for sinking of the tibial component.From the pictures of the explanted implants, residual cement and bone can be seen on the tibial and femoral components.No anomalies can be identified on the implants.As commented by the surgeon, the patient had a very soft bone and this was probably the cause for the event.From preliminary investigation, based on the pictures of the removed components and the event description, there are no elements to suspect that the event was related to a faulty device.
Event or Problem Description
Revision surgery performed at about 1 month after the primary due to tibial tray subsidence.Moto components have been successfully revised with a gmk-sphere femoral component and with gmk-revision tibial component, medial augmentation and stem.The patient has a very soft bone.
Additional Manufacturer Narrative
Revision surgery performed at about 1 month after the primary due to tibial tray subsidence.Moto components have been successfully revised with a gmk-sphere femoral component and with gmk-revision tibial component, medial augmentation and stem.The patient has a very soft bone.The branch reported to us that the surgeon concluded it was a surgical failure: the sintering was caused by a sagital resection that was too deep.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 16610802
• Report Number: 3005180920-2023-00187
• Device Sequence Number: 4817534
• Product Code: HSX
• UDI-Device Identifier: 07630030895586
• UDI-Public: 07630030895586
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 04/26/2023

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: 02.18.003RM
• Device Catalogue Number: 02.18.003RM
• Device Lot Number: 2216499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2022
• 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 Sex: Unknown