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

Model Number	02.18.003LM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 april 2021: lot 181284: (b)(4) items manufactured and released on 30-apr-2018.Expiration date: 2023-04-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Another devices involved: batch review performed on 12 april 2021: moto partial knee 02.18.If4.09.Lm tibial insert fix s4 lm - 9mm (k162084) lot.177925: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Batch review performed on 12 april 2021: moto partial knee 02.18.Tf4.Lm tibial tray fix cemented s1 lm (k162084) lot.167748: (b)(4) items manufactured and released on 13-feb-2017.Expiration date: 2022-02-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer 7 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
The event description has been corrected: the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer 7 months after primary.The surgery was completed successfully.On (b)(6) 2021, the surgeon removed the spacer they made (femur and tibia) only to implant another insert and femur to act as a spacer since the infection had not cleared up yet.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer 7 months after primary.The surgery was completed successfully.On (b)(6) 2021, the surgeon removed the spacer they made (femur and tibia) only to implant another insert and femur to act as a spacer since the infection had not cleared up yet.

• Brand Name: MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11670445
• Report Number: 3005180920-2021-00293
• Device Sequence Number: 11553592
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 04/19/2023
• Device Model Number: 02.18.003LM
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 181284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention