MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R

Model Number 02.12.0210FR

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

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 september 2020 lot 1810387: (b)(4) items manufactured and released on 11-mar-2019.Expiration date: 2024-02-27.No anomalies found related to the problem.To date, 74 items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in reporting instability due to loose ligaments.The cause of the loose ligaments is unknown.The surgeon revised the sphere insert flex right 10mm s2 to a gmk-sphere tibial insert - flex s4l - 17mm 1 year and 1 month after surgery.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• Type of Device: TIBIAL INSERT FIXED
• 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: 10697598
• MDR Text Key: 211901728
• Report Number: 3005180920-2020-00726
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K121416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2020

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: 02/27/2024
• Device Model Number: 02.12.0210FR
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 1810387
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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