MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM; KNEE CEMENTED TIBIAL TRAY

Catalog Number 02.18.TF3.LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 apr 2019: lot 160685: (b)(4) items manufactured and released on 29 october 2016.Expiration date: 2021-05-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (mdr 2017-00465).Additional implants involved: moto partial knee 02.18.003lm anatomical femoral component cemented s3 lm (k162084), lot 167863: (b)(4) items manufactured and released on 07-mar-2017.Expiration date: 2022-02-12.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any other similar reported event.Moto partial knee 02.18.If3.09.Lm tibial insert fix s3 lm - 9mm (k162084), lot 168007: (b)(4) items manufactured and released on 09-jan-2017.Expiration date: 2021-12-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

Revision surgery performed after 1 year and 7 months from the primary due to pain (the cause of pain is unknown).The surgeon revised the moto knee to a total knee and the surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM
• Type of Device: KNEE CEMENTED TIBIAL TRAY
• 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: 8560453
• MDR Text Key: 143409592
• Report Number: 3005180920-2019-00321
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030896736
• UDI-Public: 07630030896736
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Catalogue Number: 02.18.TF3.LM
• Device Lot Number: 160685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2016
• 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