MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM

Model Number 02.18.IF3.08.RM

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 12/20/2022

Event Type  Injury  

Event Description

Revision surgery at about 1 month post primary due to pain.The surgeon commented that a slight varus of the tibial baseplate could be the cause of the pain.There was no loosening/mobilization.

Manufacturer Narrative

Batch review performed on 21 december 2022: lot 2201828: (b)(4) items manufactured and released on 21-apr-2022.Expiration date: 2027-03-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional components revised: moto partial knee 02.18.004rm anatomical femoral component cemented s4 rm (k162084) lot.2207902: (b)(4) items manufactured and released on 05-july-2022.Expiration date: 2027-06-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Moto partial knee 02.18.Tf3.Rm tibial tray fix cemented s3 rm (k162084) lot.2201288: (b)(4) items manufactured and released on 04-may-2022.Expiration date: 2027-04-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM
• Type of Device: PARTIAL KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16061013
• MDR Text Key: 306263178
• Report Number: 3005180920-2022-00990
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.18.IF3.08.RM
• Device Catalogue Number: 02.18.IF3.08.RM
• Device Lot Number: 2201828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2022
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian