MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number 02.07.1203R

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 may 2023 lot 2102506: (b)(4) items manufactured and released on 04-may-2021.Expiration date: 2026-apr-(b)(4).No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: 1,5 years after primary cemented tka the patient is in pain and the surgeon diagnosed metal hypersensitivity, according to a reasonable interpretation of the report.Therefore, he decided to change the metal implants to a ceramic coated version, in order to reduce the ion release that may trigger the hypersensitivity reaction.The primary prosthesis looks correctly implanted and there is no reason to suspect a faulty or defective device; the possibility of hypersensitivity reaction is listed among the potential sources of adverse events in the product literature, but it is known that it is sometimes difficult to verify in advance and then it can intervene secondarily.It ought to be noted that the surgeon opted for a more constrained device for the revision operation, but the reasons for this choice are not specified in the report.Other device involved: gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r (k121416) lot 2001647: (b)(4) items manufactured and released on 24-jun-2020.Expiration date: 2025-jun-15.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

The patient came in reporting pain due to a nickel allergy and the cause is unknown.About 1 year and 7 months after the primary surgery, the surgeon revised all components to hinge sensitin components and resurfaced the patient's natural patella.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 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: 17181878
• MDR Text Key: 317663295
• Report Number: 3005180920-2023-00432
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819896
• UDI-Public: 07630030819896
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.07.1203R
• Device Catalogue Number: 02.07.1203R
• Device Lot Number: 2102506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2021
• 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