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

Model Number 02.07.1204L

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 5 february 2021: lot 1904222: (b)(4) items manufactured and released on 6-nov-2019.Expiration date: 2024-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional item involved in the event, batch review performed on 5 february 2021: gmk-sphere 02.12.0005l femoral component sphere cemented size 5 l (k121416) lot.1904576 lot 1904576: (b)(4) items manufactured and released on 5-sep-2019.Expiration date: 2024-08-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.The certificate of the material composition has been verified.According to this certificate, the material is conforming to the specification.

Event Description

The patient came in reporting pain and instability(probably caused by allergy) 10 months after the primary surgery.The surgeon performed an allergy test on the patient and it was observed that the patient was allergic to nickel.The surgeon revised all the components except the patella with competitor hardware.The surgery was completed successfully.The surgeon was not aware that the patient was allergic to nickel during the primary.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
• Type of Device: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11372688
• MDR Text Key: 240037656
• Report Number: 3005180920-2021-00141
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2021

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 Model Number: 02.07.1204L
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 1904222
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2019
• 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