MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM; FIXED CEMENTED TIBIAL TRAY

Model Number	02.18.TF1.RM
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 may 2021: lot 170788: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-28.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.Clinical evaluation: 1.5 years after primary uka the tibial component loosened and required revision.From the radiographs supplied, it seems that the medial proximal tibial bone lost density and became unable to sustain the baseplate, for unknown reasons.According to the surgeon's analysis, the baseplate could not be seated fully on cortical bone, particularly it did not reach the anterior tibial cortex.This is of course a good explanation, but the images we have available are not sufficient for us to confirm this hypothesis.We don't see any reason to suspect a faulty implant.
Event or Problem Description
Revision due to aseptic loosening of the tibial component 1 year and 4 months after primary.All devices were explanted and gmk sphere system was implanted.It may be that the anterior part of the tibial implant was not perfectly seated on the cortical bone.The patient has a rather high bmi.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM
• Common Device Name: FIXED CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12058170
• Report Number: 3005180920-2021-00507
• Device Sequence Number: 14446957
• Product Code: HSX
• UDI-Device Identifier: 07630030896705
• UDI-Public: 07630030896705
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 03/28/2022
• Device Model Number: 02.18.TF1.RM
• Device Catalogue Number: 02.18.TF1.RM
• Device Lot Number: 170788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/24/2021
• 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: 69 YR