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

Catalog Number 02.07.1204R

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 01 december 2023: lot 2116007: (b)(6) items manufactured and released on 31-mar-2022.Expiration date: 2027-03-17.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.

Event Description

Revision surgery due to tibial mobilization at 1 year and 6 months from the primary surgery.Insert, tibial and femoral component successfully revised with gmk revision.

Manufacturer Narrative

Clinical evaluation performed by medical affairs director on (b)(6) 2024: 1,5 years after primary cemented tka, the tibia component is mobilized and needs revision.At revision, the whole implant is exchanged to a revision system.The pre-revision radiographs show that the medial side of the tibial bone gave way and could not sustain the implant any longer.We cannot speculate on the causes of this condition; however, we see no reason to suspect a faulty implant.

• Brand Name: GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 R
• 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: 18364408
• MDR Text Key: 330996016
• Report Number: 3005180920-2023-01010
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090988
• 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,Followup
• Report Date: 02/02/2024

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: 02.07.1204R
• Device Lot Number: 2116007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2022
• 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: 77 YR
• Patient Sex: Male