MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R; KNEE CEMENTED FEMUR

Model Number	02.12.0003R
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 november 2021: lot 2000484: 70 items manufactured and released on 08-jun-2020.Expiration date: 2025-may-26.No anomalies found related to the problem.To date, 67 items of the same lot have been sold with no similar reported event.Additional device involved, batch review performed on 11 november 2021: gmk-sphere 02.12.0211crr tibial insert fixed sphere cr #2/11 mm r (k181635) lot 1901348: 60 items manufactured and released on 03-jun-2019.Expiration date: 2024-may-15.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no similar reported event.
Event or Problem Description
The patient came in reporting tightness in the knee and the cause of the tightness is unknown.The surgeon revised the liner (with a lower one) and the femoral component about 1 year after the primary surgery.The surgery was completed successfully.The femoral component was revised because the surgeon wanted to use the kinematic alignment femur on this patient.It gave better lateral coverage and the patella tracked better.Scar tissue was present but nothing excessive.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 12923765
• Report Number: 3005180920-2021-00956
• Device Sequence Number: 4907068
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• 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: 2021
• 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): 12/03/2021

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: 05/26/2025
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 2000484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2020
• 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: Female