MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM; KNEE REVISION INSERT PE

Model Number 02.09.0312H

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2022

Event Type  Injury  

Event Description

At 1 week from primary surgery the surgeon found the hinge mechanism loose, hinge pivot inside the liner, femur detached from pivot and screw free in the joint.He did open the knee, inserted the femur in the pivot and re-tightened the post locking screw (the one loose in the joint) completing the surgery successfully.The post screw was not screwed during the primary due to user error.

Manufacturer Narrative

Batch review performed on 28 june 2022 lot 2114867: (b)(4) items manufactured and released on 12-jan-2022.Expiration date: 2026-12-12.No anomalies found related to the problem.To date, 3 items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 3/12MM
• Type of Device: KNEE REVISION INSERT PE
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 15041335
• MDR Text Key: 296063553
• Report Number: 3005180920-2022-00543
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825125
• UDI-Public: 07630030825125
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130299
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.0312H
• Device Catalogue Number: 02.09.0312H
• Device Lot Number: 2114867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White