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

Model Number	02.12.0023R
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 april 2023.Lot 2112921: (b)(4) items manufactured and released on 03-nov-2021.Expiration date: 2026-10-20.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: one year after primary cemented tka in an overweight patient, discomfort and pain are reported and a surgeon different from the primary implanter performs a total revision.The index surgery ended with a femoral component internally rotated, a significantly slanted tibial tray but we have no images that can help to reconstruct the origin of these choices.It can be surmised that this position of the components may be at the origin of the pain reported by the patient.There is no reason to suspect a faulty device.
Event or Problem Description
At about 1 year after the primary, the patient came in reporting pain.The surgeon observed that the femur was too internally rotated and the cause is unknown.The surgeon revised all components to competitor components and the surgery was completed successfully.It was also noted the dislocation of natural patella.The natural patella was not resurfaced.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16831490
• Report Number: 3005180920-2023-00320
• Device Sequence Number: 11226438
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 04/28/2023

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: 02.12.0023R
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 2112921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• 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
• Patient Weight: 100 KG