MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R; KNEE CEMENTED FEMUR

Model Number	02.12.0025R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, 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.On (b)(6) 2022, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted a new femur and insert with antibiotic cement.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 june 2022: lot 2108389: (b)(4) items manufactured and released on 13-oct-2021.Expiration date: 2026-09-30.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.Additional device involved batch review performed on 28 june 2022: gmk-sphere 02.12.0510fr tibial insert fixed sphere flex size 5/10 mm r (k121416) lot 2000451: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-10.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.
Additional Manufacturer Narrative
The event reported as mdr 2022-00525 is a follow up of mdr 3005180920-2022-00267.Mdr 2022-00525 reports the same information inserted in the 3005180920-2022-00267 follow up 1.
Event or Problem Description
The event reported as mdr 2022-00525 is a follow up of mdr 3005180920-2022-00267.Mdr 2022-00525 reports the same information inserted in the 3005180920-2022-00267 follow up 1.
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.Complaint (b)(4) was filed.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.On (b)(6) 2022, 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.Complaint (b)(4) was filed.On (b)(6) 2022, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted a new femur and insert with antibiotic cement.The surgery was completed successfully.Presently, on (b)(6) 2023, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted revision knee components.The surgery was completed successfully.
Additional Manufacturer Narrative
Description of the event changed: 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.Complaint (b)(4) was filed.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.On (b)(6) 2022, 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.Complaint (b)(4) was filed.On (b)(6) 2022, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted a new femur and insert with antibiotic cement.The surgery was completed successfully.Presently, on (b)(6) 2023, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted revision knee components.The surgery was completed successfully.Data of the implantation of the revision knee components changed: (b)(6) 2023.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 14927440
• Report Number: 3005180920-2022-00525
• Device Sequence Number: 12215801
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 09/30/2026
• Device Model Number: 02.12.0025R
• Device Catalogue Number: 02.12.0025R
• Device Lot Number: 2108389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 06/17/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/12/2022; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2021
• 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