MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 LM - 9MM; KNEE IMPLANT: TIBIAL INSERT FIXED

Model Number 02.18.IF7.09.LM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Joint Disorder (2373)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 february 2020: lot 168031: (b)(4) items manufactured and released on 16-feb-2017.Expiration date: 2022-01-30.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 since 1-1-2016.

Event Description

The patient complained that his knee felt "loose".All components were well fixed and the poly used in the primary case was in good condition when removed.1 year and 4 months after primary the poly has been upsized to give the patient more stability in the knee.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 LM - 9MM
• Type of Device: KNEE IMPLANT: TIBIAL INSERT FIXED
• 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: 9738636
• MDR Text Key: 188737672
• Report Number: 3005180920-2020-00080
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896477
• UDI-Public: 07630030896477
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: 02.18.IF7.09.LM
• Device Catalogue Number: 02.18.IF7.09.LM
• Device Lot Number: 168031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2017
• 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: 74 YR