MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L; KNEE CEMENTED FEMUR

Model Number	02.12.0022L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 november 2020: lot 188195: (b)(4) items manufactured and released on 21-dec-2018.Expiration date: 2023-12-06.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.Additional devices involved: batch review performed on 03 november 2020: gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l (k090988) lot 1902670: (b)(4) items manufactured and released on 25-jul-2019.Expiration date: 2024-07-07.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 02.12.0210fl tibial insert fixed sphere flex #2/10 mm l (k121416) lot 1902467: (b)(4) items manufactured and released on 06-jun-2019.Expiration date: 2024-05-21.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.
Event or Problem Description
Primary surgery was performed on (b)(6) 2019.When the patient came to the hospital on (b)(6) 2020, the surgeon discovered the infection.The surgeon once removed the implants from the patient's body and inserted the cement mold spacer on (b)(6) 2020.Revision surgery will be planned with the competitor's device after the following up.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10867712
• Report Number: 3005180920-2020-00820
• Device Sequence Number: 16774666
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2019

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: 12/06/2023
• Device Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 188195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/19/2020
• 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