MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; KNEE FEMORAL CEMENTED COMPONENT

Model Number	02.12.0004R
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 december 2021: lot 183487: (b)(4).Expiration date: 2023-07-22.No anomalies found related to the problem.(b)(4).Additional device involved: batch review performed on 02 december 2021: gmk-sphere 02.12.0410crr tibial insert fixed sphere cr #4/10 mm r (k181635) lot 185620: (b)(4).Expiration date: 2023-10-01.No anomalies found related to the problem.(b)(4).
Event or Problem Description
At 3 years after the primary, the patient came in reporting instability and hyperextension and the cause is unknown.The surgeon revised the liner and femur.The surgery was completed successfully.The surgeon used a thicker liner to provide greater varus/valgus stability and revising the femoral component to give the patient a post to reduce hyperextension.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: KNEE FEMORAL CEMENTED COMPONENT
• 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: 13001323
• Report Number: 3005180920-2021-01010
• Device Sequence Number: 20012608
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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: 07/22/2023
• Device Model Number: 02.12.0004R
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 183487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2018
• 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: Unknown