MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE S3 LEFT MEDIAL

Catalog Number 02.18.003LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on 21 august 2017.Lot 163669: (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-06-12.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.Moto partial knee - tibial insert fix size s3 left medial - 8mm, code 02.18.If3.08.Lm, lot.161220 (k162084) (b)(4) items manufactured and released on 24 october 2016.Expiration date: 2021-06-01.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.Moto partial knee - tibial tray fix cemented size s3 left medial, code 02.18.Tf3.Lm, lot.160685 (k162084) (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 without any similar reported event.

Event Description

The patient came in complaining of pain.The cause of pain is unknown.The surgeon revised all medacta hardware.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: MOTO PARTIAL KNEE - ANATOMICAL FEMORAL COMPONENT CEMENTED SIZE S3 LEFT MEDIAL
• Type of Device: ANATOMICAL FEMORAL COMPONENT CEMENTED
• 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, 6874 ; SZ 6874
• MDR Report Key: 6812707
• MDR Text Key: 83473611
• Report Number: 3005180920-2017-00465
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• 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: Other
• Type of Report: Initial
• Report Date: 08/23/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Catalogue Number: 02.18.003LM
• Device Lot Number: 163669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2016
• 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
• Patient Age: 73 YR