MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO LATERAL PARTIAL KNEE SYSTEM; KNEE TIBIAL INSERT

Model Number	02.18.IF6.08.LLRL
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 sept 2024.Lot 2238953: (b)(4) items manufactured and released on 10-nov-2022.Expiration date: 2027- 10 - 27.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery due to subsidence of tibial baseplate.Primary surgery date unknown.All compentent revised and gmk spherika successfully implanted.

• Brand Name: MOTO LATERAL PARTIAL KNEE SYSTEM
• Common Device Name: KNEE TIBIAL INSERT
• 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: 20366841
• Report Number: 3005180920-2024-00798
• Device Sequence Number: 3795876
• Product Code: HSX
• UDI-Device Identifier: 07630040721028
• UDI-Public: 07630040721028
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K183029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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 Model Number: 02.18.IF6.08.LLRL
• Device Lot Number: 2238953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2022
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Hispanic
• Patient Race: White