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
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: KNEE IMPLANT: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9738636
• Report Number: 3005180920-2020-00080
• Device Sequence Number: 19286409
• Product Code: HSX
• UDI-Device Identifier: 07630030896477
• UDI-Public: 07630030896477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 01/30/2022
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/21/2020
• 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: 74 YR