MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 9MM

Model Number	02.18.IF5.09.LM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 30.03.2021: lot 2001399: 14 items manufactured and released on 20-may-2020.Expiration date: 2025-05-05.No anomalies found related to the problem.To date, 5 items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medacta medical affairs manager insert revision performed 2 months after implantation in a (b)(6) year old man.No information concerning the presence of symptoms that generated the clinical suspect of infection is available.Short term polyethylene wear has no clinical origin, visual inspection can give more information about the cause of this event.Preliminary investigation performed by medacta knee r&d manager: revision surgery of a moto implant after 2 months from primary due to infection.During revision surgery, the knee was cleaned and the inlay was changed.The surgeon noticed that the removed insert was worn out in relation to the time of implantation.From the picture sent of the explanted component, it is not possible to evaluate if the insert is abnormally worn-out.We can see that, in the central portion of the inlay, the inserts is slightly pressed, with the negative shape of the femoral component; this is related to the deformation of the plastic component under the static body load, and something expected even if related to a short time of implantation.We can also notice some small dents and craters on the articular most likely caused during the attempt to remove the insert.Further and deeper considerations if the part will be sent back for visual inspection.Visual inspection performed by medacta knee r&d manager: during revision surgery, the knee was cleaned and the inlay was changed.The surgeon noticed that the removed insert was worn out in relation to the time of implantation.From visual inspection of the explanted component, we can see that, in the central portion of the inlay, the insert is slightly pressed, with the negative shape of the femoral component; this is related to the deformation of the plastic component under the static body load, and something expected independently from the time of implantation.We can also notice some small dents and craters on the articular surface, most likely caused by the presence of a third body.Entity of these small signs, should not had compromised performances of the device in the time of implantation.
Event or Problem Description
2 months after the primary surgery the patient came in due to suspecting an infection (finally the infection was not confirmed), the knee joint was a washout and the inlay was changed.During the surgery, it was noticed that the inlay was worn out.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 LM - 9MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11700204
• Report Number: 3005180920-2021-00311
• Device Sequence Number: 14327735
• Product Code: HSX
• UDI-Device Identifier: 07630030896231
• UDI-Public: 07630030896231
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/21/2021

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: 05/05/2025
• Device Model Number: 02.18.IF5.09.LM
• Device Catalogue Number: 02.18.IF5.09.LM
• Device Lot Number: 2001399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/21/2021
• 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
• Patient Age: 60 YR
• Patient Weight: 80