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

Model Number 02.18.003LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 03/16/2021

Event Type  Injury  

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 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.

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 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
• Type of Device: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11670445
• MDR Text Key: 245558375
• Report Number: 3005180920-2021-00293
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• Combination Product (y/n): N
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention