MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R; KNEE TIBIAL TRAY FIXED CEMENTED

Catalog Number 02.07.1202R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/25/2023

Event Type  Injury  

Event Description

At about 1 month after the primary, the patient came in reporting pain and discomfort and the cause is unknown.The surgeon revised the femur, insert and tibial tray with revision components.The surgery was completed successfully.Any issue with the implants detected.

Manufacturer Narrative

Batch review performed on 01-sep-2023.Lot 2119173: (b)(4) items manufactured and released on 26-apr-2022.Expiration date: 2027-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: gmk-sphere 02.12.0021r femoral component sphere cemented size 1+ r (k140826) lot 2103456: (b)(4) items manufactured and released on 08-jun-2021.Expiration date: 2026-05-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Gmk-sphere 02.12.E0212fr tibial insert fixed sphere flex size 2/12 mm r e-cross (k202022) lot 2105597: (b)(4) items manufactured and released on 06-jul-2021.Expiration date: 2026-06-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Type of Device: KNEE TIBIAL TRAY FIXED CEMENTED
• 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: 17823868
• MDR Text Key: 324330025
• Report Number: 3005180920-2023-00742
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 2119173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2022
• 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 Sex: Female