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

Model Number	02.12.0003R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 months after the primary surgery, pain was reported by the patient with significant limited flexion (impossibility for the patient to bend the leg beyond 30 degrees).The surgeon lifted the anterior tibial tuberosity to access the prosthesis and revised successfully the femoral component size 3 with size 2 and tibial insert (same size).
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director.Less than one year after primary cemented tka, the patient has a very pronounced flexion deficit and the surgeon decided to replace the femoral component.From the radiographs supplied, it is possible that the flexion deficit was caused by a femoral component slightly too large as well as by a defect in the rotational orientation of the prosthesis.The femoral component was downsized, but we have no final standing x-ray of the revised knee.The root cause is therefore, most probably, component oversizing and malpositioning, but of course we do not have information on the clinical status, and mostly importantly, the situation with the soft tissues.Mysolution department analysis: the analysis of the myknee process did not find any deviation from the standard procedure.Each step has been performed correctly.In the received x-rays the femoral component shows the implant with a deviation from the parameters of the validated planning.The distal medial cut is a few millimeters bigger than the planned cut, meaning there is some varus deviation from the parameters validated; the flexion given to the femoral component was more than planned.Batch review performed on 08 march 2023.Lot 2112894: (b)(4) items manufactured and released on 13-dec-2021.Expiration date: 2026-11-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional component revised: gmk-sphere 02.12.0210fr tibial insert fixed sphere flex siye 2/10 mm r (k121416) lot 2106544: (b)(4) items manufactured and released on 02-sep-2021.Expiration date: 2026-07-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R
• Common Device Name: KNEE 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: 16672282
• Report Number: 3005180920-2023-00190
• Device Sequence Number: 6379483
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 2112894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2021
• 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 Age: 67 YR
• Patient Sex: Female