MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 2 R; CONSTRAINED CEMENTED FEMORAL COMPONENT

Model Number 02.09.2602R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 february 2022 lot 1810684: 19 items manufactured and released on 23-may-2019.Expiration date: 2024-04-21.No anomalies found related to the problem.To date, 15 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.07.Fcl16105 extension stem - fluted ø 16 l 105 (k120790) lot.187635 batch review performed on 07 february 2022 lot 187635: 20 items manufactured and released on 12-dec-2018.Expiration date: 2023-11-21.No anomalies found related to the problem.To date, 13 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.07.Cm25 centred 3dmetal tibial cone m h25 (k170149) lot.172468 batch review performed on 07 february 2022 lot 172468: 50 items manufactured and released on 23-jan-2018.Expiration date: 2023-01-14.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.05.02dw femoral wedge distal # 2/8mm (k102437) lot.1811779 batch review performed on 07 february 2022 lot 1811779: 27 items manufactured and released on 29-apr-2019.Expiration date: 2024-04-13.No anomalies found related to the problem.To date, 11 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.05.02dw femoral wedge distal # 2/8mm (k102437) lot.183229 batch review performed on 07 february 2022 lot 183229: 27 items manufactured and released on 05-july-2018.Expiration date: 2023-06-13.No anomalies found related to the problem.To date, 15 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.09.0212h fixed tibial insert # 2/12mm (k130299) lot.1904689 batch review performed on 07 february 2022 lot 1904689: 10 items manufactured and released on 27-june-2019.Expiration date: 2024-06-15.No anomalies found related to the problem.To date, 5 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.07.0036rp patella resurfacing # 4 (k113571) lot.2000634 batch review performed on 07 february 2022 lot 2000634: 330 items manufactured and released on 26-feb-2020.Expiration date: 2025-02-15.No anomalies found related to the problem.To date, 311 items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-hinge 02.07.Fcl14105 extension stem - fluted ø 14 l 105 (k120790) lot.1905621 batch review performed on 07 february 2022 lot 1905621: 15 items manufactured and released on 13-nov-2019.Expiration date: 2024-11-03.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without any similar reported event.

Event Description

The patient had primary knee surgery on (b)(6) 2020.On (b)(6) 2020, the surgeon decided to resurface the patient's patella.The reason for this additional procedure is unknown.On (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.In 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon removed all implants and implanted a spacer.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon removed the spacer and implanted a hinge knee.The surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed the femur, stem extension, augments, poly, and patella, performed a washout, and then reimplanted the patient with new hardware.The surgery was completed successfully.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 2 R
• Type of Device: CONSTRAINED CEMENTED FEMORAL COMPONENT
• 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: 13470615
• MDR Text Key: 285350019
• Report Number: 3005180920-2022-00072
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825422
• UDI-Public: 07630030825422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.09.2602R
• Device Catalogue Number: 02.09.2602R
• Device Lot Number: 1810684
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2019
• 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
• Patient Sex: Female