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

Model Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 september 2021: lot 184854: (b)(6) items manufactured and released on 18-sept-2018.Expiration date: 2023-09-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Additional devices involved: batch reviews performed on 23 september 2021: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 184854: (b)(4) items manufactured and released on 18-sept-2018.Expiration date: 2023-09-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Gmk-sphere 02.12.0510fr tibial insert fixed sphere flex size 5/10 mm r (k121416) lot 2010602: (b)(4) items manufactured and released on 29-oct-2020.Expiration date: 2025-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.12.0510fr tibial insert fixed sphere flex size 5/10 mm r (k121416) lot 184907: (b)(4) items manufactured and released on 09-oct-2018.Expiration date: 2023-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 similar events reported.
Event or Problem Description
2 years and 10 months after the primary surgery a second revision surgery was performed due to infection.The surgeon revised all implants and implanted patella resurfacing.Over 3 months ago, on (b)(6) 2021, this patient had a liner (lot 184907 )swap due to an infection this event wasn't reported previously due to agent error.
Additional Manufacturer Narrative
In the initial mdr the second batch review reported was wrong and the clinical evaluation was missing.Here below the correct batch on the lot 184114 and the clinical evaluation.Batch review performed on 23 september 2021: lot 184114:(b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar event reported.Clinical evaluation performed on 8 october 2021 by medacta medical affairs manager: reinfection in cemented tka, 3 months after first revision.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12630755
• Report Number: 3005180920-2021-00804
• Device Sequence Number: 19906065
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 184854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 110