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

Model Number	02.12.0004L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 2201125:(b)(4) items manufactured and released on (b)(6)2022.Expiration date: 2027-04-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved batch review performed on (b)(6) 2022 gmk-sphere 02.12.0411fl tibial insert fixed sphere flex #4/11 mm l (k140826) lot 187221: (b)(4) items manufactured and released on (b)(6) 2019.Expiration date: 2024-01-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical affairs director: one month after primary tka the patient complains about stiffness and inability to reach full extension.The surgeon revised the tibial insert to a thinner one and the femoral component (reason not specified, images not available).There is no reason to suspect that this adverse event is due to defective devices.
Event or Problem Description
At about 1 month and 3 weeks after the primary surgery, the patient came in reporting pain and stiffness, and upon examination, the patient was unable to straighten to full extension.The surgeon decreased the poly size and also revised the femur.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15868553
• Report Number: 3005180920-2022-00888
• Device Sequence Number: 5258851
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/28/2022

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 Model Number: 02.12.0004L
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 2201125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2022
• 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