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

Catalog Number 02.18.TF3.LM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed on 13 december 2017 by medical affairs: unicompartmental knee revision surgery few days after primary implantation in a (b)(6) year-old woman.The patient was complaining about pain and radiographic images show the presence of an anterior subsided tibial component.According to the report, the poor quality of the bone may have contributed to this event.There is no reason to suspect a faulty device.Preliminary investigation performed on the pictures received from the complainer on (b)(6) 2017: unicompartmental knee revision surgery few days after primary implantation in a (b)(6) year-old woman.Patient started having increased pain few days after surgery.The patient was complaining about pain and x-ray images show the presence of an anterior subsided unicompartmental tibial component.No scratches or signs of implant failure can be observed in the pictures in our hand.Tibial bone looked well adherent to the explanted tibial device.According to the report, the poor quality of the bone may have contributed to this event.There is no reason to suspect that this event is implant related.Batch review performed on 14 december 2017: lot 167747: (b)(4) items manufactured and released on 21 feb 2017.Expiration date: 2022-02-08 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.Moto partial knee tibial insert fix s3 lm - 9mm reference 02.18.If3.09.Lm (k162084) lot 167788: (b)(4) items manufactured and released on 9 jan 2017 expiration date: 2021-12-12 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.

Event Description

The patient came in complaining of pain.The patient had fractured her tibia.The surgeon revised the entire moto system and replaced it with a total knee.The surgery was completed successfully.The bone fracture cause is unknown.The patient did not report any trauma.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM
• Type of Device: TIBIAL TRAY FIX 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, 6874 ; SZ 6874
• MDR Report Key: 7120563
• MDR Text Key: 94942723
• Report Number: 3005180920-2017-00754
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896736
• UDI-Public: 07630030896736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Catalogue Number: 02.18.TF3.LM
• Device Lot Number: 167747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR