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

Catalog Number	02.18.TF3.LM
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TIBIAL TRAY FIX CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7120563
• Report Number: 3005180920-2017-00754
• Device Sequence Number: 13785941
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 02/05/2022
• Device Catalogue Number: 02.18.TF3.LM
• Device Lot Number: 167747
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/15/2017
• 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: 82 YR