MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM

Catalog Number	02.18.TF2.RM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received from the agent on feb 8, 2019: no trauma occurred.The patient has a standard lifestile (no excessively active).Batch review performed on 25 february 2019: lot 170790: (b)(4) items manufactured and released on 27-jun-2017.Expiration date: 2022-06-07.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.Clinical evaluation performed by medical affairs director: knee revision surgery due to tibial fracture occurred few weeks after primary cemented unicompartmental knee arthroplaty in a (b)(6) year-old woman.The poor quality of the xray images may induce in error; the picture labelled "post-op" leaves a suspect of overhang, cortical bone compromise and potential orientation difficulties, difficult to judge because of the partial image.The actual relevance of these details on the subsequent fracture is unknown.There is no report of a traumatic event, therefore the normal bone weakening due to the tibial preparation in an elderly woman may have favoured the formation of the fracture.
Event or Problem Description
Revision surgery performed due to a loosening of the tibial tray caused by a bone fracture close to the anterior fixation peg.After a few weeks from the unicompartmental knee replacement surgery, performed with a moto implant on (b)(6) 2018, despite post-op x-rays were good, the patient came back to the surgeon complaining about mild medial knee pain.After a further clinical investigation, the surgeon observed a bone fracture of the tibial plate close to the anterior fixation peg.After monitoring period of the case, on (b)(6) 2019, the surgeon decided to reoperate the patient, all components were removed.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 RM
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8370496
• Report Number: 3005180920-2019-00103
• Device Sequence Number: 19338902
• Product Code: HSX
• UDI-Device Identifier: 07630030896729
• UDI-Public: 07630030896729
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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: 06/07/2022
• Device Catalogue Number: 02.18.TF2.RM
• Device Lot Number: 170790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/26/2019
• 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: 76 YR
• Patient Weight: 65