MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/13 MM R; KNEE TIBIAL INSERT

Catalog Number 02.12.0613CRR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Laxity (4526)

Event Date 02/28/2024

Event Type  Injury  

Event Description

At about 4 years 2 months after the primary, the patient came in reporting instability due to laxity.The surgeon revised the liner cr with a flex e-cross liner (same size) because it is more congruent on medial side and offers more stability.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 11 march 2024: lot 185635: (b)(4) items manufactured and released on 20-sep-2018.Expiration date: 2023-09-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 6/13 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: 18992940
• MDR Text Key: 338814614
• Report Number: 3005180920-2024-00165
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630040707824
• UDI-Public: 07630040707824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181635
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Catalogue Number: 02.12.0613CRR
• Device Lot Number: 185635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2018
• 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