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

Model Number	02.12.0025L
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment 10 months after the primary surgery and it was determined that the patient needed to be converted because the quadricep was not strong enough and was causing the knee to hyperextend.All components were revised and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 09-dec-2021.Lot 1909485: (b)(4).Expiration date: 2025-mar-02.No anomalies found related to the problem.(b)(4).Additional devices involved: gmk-sphere 02.12.0512fl tibial insert fixed sphere flex size 5/12 mm l (k121416) lot.1909425; lot 1909425: (b)(4).Expiration date: 2024-nov-13.No anomalies found related to the problem.(b)(4).Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.1909601; lot 1909601: (b)(4).Expiration date: 2025-mar-04.No anomalies found related to the problem.(b)(4).Gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot.2006038; lot 2006038: (b)(4).Expiration date: 2025-jul-22.No anomalies found related to the problem.(b)(4).

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• 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: 12982990
• Report Number: 3005180920-2021-00969
• Device Sequence Number: 5694616
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/13/2021

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: 03/02/2025
• Device Model Number: 02.12.0025L
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 1909485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2020
• 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