MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM

Model Number 02.18.IF2.10.LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 19 may 2020: lot 172346: (b)(4) items manufactured and released on 24-oct-2017.Expiration date: 2022-10-11.No anomalies found related to the problem.To date, 4 items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in, 9 months after primary surgery, reporting tightness of the knee.The surgeon revised the 10mm poly with an 8mm poly and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 10MM
• Type of Device: KNEE TIBIAL INSERT
• 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: 10127318
• MDR Text Key: 194325122
• Report Number: 3005180920-2020-00312
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895890
• UDI-Public: 07630030895890
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: 02.18.IF2.10.LM
• Device Catalogue Number: 02.18.IF2.10.LM
• Device Lot Number: 172346
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2017
• 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: 71 YR