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

Model Number	02.12.0005R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 13.08.2020: lot 172741: (b)(4) items manufactured and released on 13-sep-2017.Expiration date: 2022-08-29.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: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.172921.Batch review performed by medacta regulatory affairs department on 13.08.2020: lot 172921: (b)(4) items manufactured and released on 26-sep-2017.Expiration date: 2022-09-07.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.Gmk-sphere 02.12.0413fr tibial insert fixed sphere flex size 4/13 mm r (k140826) lot.187260.Batch review performed on 02 september 2020: lot 187260: (b)(4) items manufactured and released on 20-dec-2018.Expiration date: 2023-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without with one similar event reported.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.On (b)(6) 2019, the patient came in complaining of a clicking noise and instability of the knee.The surgeon revised the 10mm poly with a 13mm poly and the surgery was completed successfully.Presently, on (b)(6) 2020, the patient came in and the surgeon took post-op x-rays.The surgeon decided to revise the patient's femoral component ((b)(6) 2020), tibial tray, and insert due to a mismatched flexion extension and removed all components.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: FEMORAL KNEE COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10482597
• Report Number: 3005180920-2020-00533
• Device Sequence Number: 19856808
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 08/29/2022
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 172741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 09/02/2020
• 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