MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM

Model Number	02.18.003LM
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a loose femoral component and the cause is unknown.The surgeon revised all components almost 1 year and 3 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 april 2022.Lot 2007868: (b)(4) items manufactured and released on 10-nov-2020.Expiration date: 2025-10-11.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d manager: revision surgery of a moto medial uni knee after 1 year and 3 months from primary implantation due to femoral loosening.Visual inspection of the explanted femoral component, tibial component and tibial insert sent back for investigation.No residual cement can be seen in the internal surface of the femoral component.Cement on the femoral remained probably adherent to the bone.This could be a sign of poor interdigitation between cement and implant.Residual cement can be seen on the distal surface of the tibial baseplate.Many factors could had played a role in the lack of interdigitation between implant and cement, such as cemenentation process, temperature, wetting of the implant; those are most likely not implant related.No further elements that can be considered relevant for the event can be noted.From visual inspection there is no evidence that the event is related to a faulty device.

• Brand Name: MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
• Common Device Name: ANATOMICAL FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14361895
• Report Number: 3005180920-2022-00348
• Device Sequence Number: 4907440
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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 Expiration Date: 11/10/2025
• Device Model Number: 02.18.003LM
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 2007868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: Female