MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM; KNEE TIBIAL INSERT

Model Number	02.07.0410SCF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 october 2019: lot 185114: (b)(4) items manufactured and released on 20-sep-2018.Expiration date: 2023-08-30.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 screw of the sc inlay has loose.The surgeon has used the torque limiter to fix the screw.Revision was performed 3 months and 20 days after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020 lot 185114: 25 items manufactured and released on (b)(6) 2018.Expiration date: 2023-08-30.No anomalies found related to reported problems.To date, 7 items of the same lot have been already sold without any other similar reported event related to unscrewing or intra-prosthetic dislocation.Clinical evaluation few months after tka, presumably a revision tka, an intra-prosthetic dislocation occurs and requires re-operation to apply a new tibial insert.Subsequent to the second operation, the patient got an infection, whose outcome is not known.The cause of the intraprosthetic dislocation is unknown.According to report, the safety screw is found loose in the joint.In our experience, one cause for self-unscrewing of these screws is insufficient tightening torque applied at the time of surgery, but we cannot state that this was the cause in this specific case.Though very unusual, it is possible that the absence of the safety screw allowed the insert to dislocate from the tibial baseplate, perhaps in a challenging movement made by the patient.Another possibility for the intraprosthetic dislocation is that the insert was not fully clipped at index surgery, but of course we have no evidence of this either.In this condition, full tightening of the safety screw is not possible.
Event or Problem Description
The patient came in for a post-op appointment reporting clicking noise into the left joint, 3 months and 20 days after the primary surgery.The x-rays analysis revealed an intra-prosthetic dislocation of the inlay from the tibial baseplate and the inlay locking screw loosened.The inlay and the locking screw have been revised successfully.3 days after the revision surgery ((b)(6) 2019) the patient's knee got infected (staphylococcus capitis).The surgeon did an i&d and no implant has been revised at that time.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9237713
• Report Number: 3005180920-2019-00896
• Device Sequence Number: 13491555
• Product Code: JWH
• UDI-Device Identifier: 07630030817656
• UDI-Public: 07630030817656
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 08/30/2023
• Device Model Number: 02.07.0410SCF
• Device Catalogue Number: 02.07.0410SCF
• Device Lot Number: 185114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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