MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0517FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 april 2022: lot 186084: (b)(4) items manufactured and released on 16-oct-2018.Expiration date: 2023-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional devices involved.Batch reviews performed on 20 april 2022: gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r (k121416) lot 180368: (b)(4) items manufactured and released on 08-may-2018.Expiration date: 2023-04-24.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 176249: (b)(4) items manufactured and released on 29-nov-2017.Expiration date: 2022-11-15.No anomalies found related to the problem.To date, all items of the same lot have been sold with another similar reported event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.On (b)(6) 2021, the patient came in reporting instability due to laxity and the cause of the laxity was unknown.The surgeon revised the gmk-sphere tibial insert - flex s5r - 14 mm with a gmk-sphere tibial insert - flex s5r - 17 mm and the surgery was completed successfully.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.Presently, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.
Event or Problem Description
On (b)(6) 2022, the surgeon removed the femur and insert that was implanted to act as a spacer (on (b)(6) 2022) and implanted a new femur and insert with antibiotic cement.The surgery was completed successfully.This spacer removal was reported in a new medacta complaint.Reported to fda as mdr 3005180920-2022-00525 for error.
Additional Manufacturer Narrative
On (b)(6) 2022, the surgeon removed the femur and insert that was implanted to act as a spacer (on (b)(6) 2022) and implanted a new femur and insert with antibiotic cement.The surgery was completed successfully.This spacer removal was reported in a new medacta complaint.Reported to fda as mdr 3005180920-2022-00525 for error.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/17 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 14157895
• Report Number: 3005180920-2022-00267
• Device Sequence Number: 5932126
• Product Code: JWH
• UDI-Device Identifier: 07630030826863
• UDI-Public: 07630030826863
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: 02.12.0517FR
• Device Catalogue Number: 02.12.0517FR
• Device Lot Number: 186084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male