MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L; KNEE TIBIAL TRAY

Catalog Number 02.07.1204L

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02-apr-2024.Lot 168504: 99 items manufactured and released on 29-mar-2017.Expiration date: 2022-03-21.No anomalies found related to the problem.To date, 95 items of the same lot have been sold with no similar reported event during the period of review.Additional components involved: gmk-sphere 02.12.0024l femoral component sphere cemented size 4+ l (k1408269) lot 163999: (b)(4) items manufactured and released on 22-sep-2016.Expiration date: 2021-09-07.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.Gmk-sphere 02.12.0414fl tibial insert fixed sphere flex size 4/14 mm l (k121416) lot 144605: (b)(4) items manufactured and released on 24-sep-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

At about 6 years and 7 months after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised all components to hinge components.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
• Type of Device: KNEE TIBIAL TRAY
• 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: 19178382
• MDR Text Key: 341002488
• Report Number: 3005180920-2024-00243
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• 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: 04/25/2024

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 Expiration Date: 03/21/2022
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 168504
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2017
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 95 KG