MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM; PARTIAL KNEE FEMORAL COMPONENT

Catalog Number	02.18.005RM
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent primary surgery on (b)(6) 2023.During an arthroscopy surgery performed because the patient felt pain, it was noticed avascular necrosis of the non-prosthetic lateral femur.No issue was detected on the implants.No infection and no allergy.As far as we know, the patient has no bone pathology.On (b)(6) 2023, the patient has been successfully revised to a gmk-sphere system.
Additional Manufacturer Narrative
Batch review performed on 07-mar-2024.Lot 2106609: (b)(4) items manufactured and released on 15-jul-2021.Expiration date: 2026-07-05.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.Additional implants involved, batch review performed on 07-mar-2024: moto partial knee 02.15.005r patello femoral joint s5 r (k200122) lot 2203778: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-05-01.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.Moto partial knee 02.15.E038 moto e-cross patella d38 (k213071) lot 2110551: (b)(4) items manufactured and released on 28-dec-2021.Expiration date: 2026-12-14.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.Moto partial knee 02.18.Tf5.Rm tibial tray fix cemented s5 rm (k162084) lot 2105882: (b)(4) items manufactured and released on 02-aug-2021.Expiration date: 2026-07-21.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.Moto partial knee 02.18.If5.09.Rm tibial insert fix s5 rm - 9mm (k162084) lot 2106134: (b)(4) items manufactured and released on 06-sep-2021.Expiration date: 2026-07-11.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.
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department.About 8 months after partial knee replacement (medial unicompartmental + patello-femoral), the patient is in pain and an arthroscopy reveals that the lateral condyle has gone through an avascular necrosis degenerative process.For this reason, disease progression, conversion to a total knee is required and the formerly implanted devices need to be retrieved, even though still working properly.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM
• Common Device Name: PARTIAL 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: 18864974
• Report Number: 3005180920-2024-00100
• Device Sequence Number: 18202794
• Product Code: HSX
• UDI-Device Identifier: 07630030895623
• UDI-Public: 07630030895623
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 06/05/2024

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: 07/05/2026
• Device Catalogue Number: 02.18.005RM
• Device Lot Number: 2106609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2021
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG