MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM; TIBIAL INSERT FIXED

Catalog Number 02.07.0412PSF

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 17 may 2018; lot 142826: (b)(4) items manufactured and released on 02 october 2014.Expiration date: 2019-08-31; 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.Clinical evaluation performed by medical affairs on 17 may 2018; screw refixation surgery is required 2,5 years after primary tka.Radiographic images show the presence of a loose insert fixation screw.This event may be due to insufficient tightening torque but the real cause can't be determined.Immediate repositioning of a new screw is strongly recommended.

Event Description

The patient came in complaining of pain 2 years and 7 months after primary.The screw disassociated from the poly insert.The surgeon removed the screw arthroscopically.The surgery was completed successfully.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/12MM
• Type of Device: TIBIAL INSERT FIXED
• 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: 7522287
• MDR Text Key: 108537113
• Report Number: 3005180920-2018-00334
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030817748
• UDI-Public: 07630030817748
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.07.0412PSF
• Device Lot Number: 142826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2014
• 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: 62 YR