MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM; UNICOMPARTIMENTAL KNEE TIBIAL TRAY CEMENTED

Model Number	02.18.TF3.LM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2022.Lot 2105334: (b)(4) items manufactured and released on 07-jun-2021.Expiration date: 2026-05-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event during the period of review.Investigation performed by r&d project manager.From the description of the event it is not possible to establish the real cause for the tibia plateau fracture.The additional information from the agent highlights the surgeon's request to have a tibia keel preparation line to line with final implant; in addition the surgeon do not want to place the implant with a 1 mm offset from the sagittal tibial resection.The current moto tibia finishing devices (tibia templates and trial tibia baseplate) have been designed to guarantee a final implant positioning with 1 mm of offset from the sagittal resection; we could imagine that the surgeon may tried to put the final implant in contact with sagittal plane, forcing the final position.If so, the keel preparation is 1 mm far from the implant keel and , during implant impactions, the implant keel could have generated the subchondral fracture.
Event or Problem Description
Revision due to tibial bone fracture 3 weeks after primary.The surgeon used a plate and screws to fix the fracture.Following the fracture repair, the surgeon replaced the tibial insert.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director on 2 september 2022: few weeks after uka, a bone fracture of the tibial plateau occurs, causes undescribed.The surgeon repairs the fracture using synthesis products by a different manufacturer.As customary, the tibial insert is replaced.The metallic components seemed to be working properly and were left in place.No radiographs were supplied, therefore the analysis is based only on the narrative in the report.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM
• Common Device Name: UNICOMPARTIMENTAL KNEE TIBIAL TRAY CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14696266
• Report Number: 3005180920-2022-00455
• Device Sequence Number: 20165304
• Product Code: HSX
• UDI-Device Identifier: 07630030896736
• UDI-Public: 07630030896736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/26/2022

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: 05/18/2026
• Device Model Number: 02.18.TF3.LM
• Device Catalogue Number: 02.18.TF3.LM
• Device Lot Number: 2105334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown