MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S7 RM

Catalog Number	02.18.TF7.RM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Update 09 october 2018: the pathogen is not available.Batch review performed on 09 october 2018.Lot 167761: (b)(4) items manufactured and released on 02 february 2017.Expiration date: 2022-01-24.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 anatomical femoral component cemented s6 rm reference 02.18.006rm (k162084).Lot 163690: (b)(4) items manufactured and released on 12 october 2016.Expiration date: 2021-06-12.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.Moto partial knee tibial insert fix s7 rm - 8mm reference 02.18.If7.08.Rm, (k162084).Lot 167841: (b)(4) items manufactured and released on 14 december 2016.Expiration date: 2021-11-29.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
Revision surgery performed due to infection after about 2 years from primary.This is the second revision surgery due to infection for this patient.The surgeon removed all medacta hardware and implanted a spacer at an unknown date.On (b)(6) 2018 the surgeon removed the spacer and implanted permanent hardware.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S7 RM
• Common Device Name: TIBIAL TRAY FIX CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7951007
• Report Number: 3005180920-2018-00766
• Device Sequence Number: 1531702
• Product Code: HSX
• UDI-Device Identifier: 07630030896828
• UDI-Public: 07630030896828
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 01/24/2022
• Device Catalogue Number: 02.18.TF7.RM
• Device Lot Number: 167761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/10/2018
• 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: 72 YR