MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R; KNEE TIBIAL INSERT

Catalog Number 02.12.0510FR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21-mar-2024.Lot 2212770: (b)(4) items manufactured and released on 03-aug-2022.Expiration date: 2027-07-14.No anomalies found related to the problem.To date, all the items of the same lot have been sold with another similar reported event during the period of review.Other device involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 2212675: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-24.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.

Event Description

At about 1 year and 3 months after primary, the patient came in reporting discomfort due to the inability to reach full flexion and the cause is unknown.The surgeon revised the insert and tibia.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
• Type of Device: KNEE TIBIAL INSERT
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19077268
• MDR Text Key: 339773849
• Report Number: 3005180920-2024-00210
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826740
• UDI-Public: 07630030826740
• Combination Product (y/n): N
• 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: 04/10/2024

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 Catalogue Number: 02.12.0510FR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2022
• 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: 51 YR
• Patient Sex: Male