MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R; KNEE CEMENTED FEMUR

Model Number	02.12.0002R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-december-2020: lot 1909465: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 17-feb-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs director: few weeks after primary tka a femoral fracture is identified.From the images reported, it seems that a significant anterior notching took place, probably at the time of surgery, and as the patient's bone is evidently porotic and weak, the fracture occurred even in absence of trauma.No reason to suspect a faulty device as the cause for this adverse event.
Event or Problem Description
Additional surgery performed 1 month after primary due to femoral condyle fracture.The surgeon fixed the fracture with a locking plate.The patient bone was weak.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11001864
• Report Number: 3005180920-2020-00892
• Device Sequence Number: 792583
• Product Code: JWH
• UDI-Device Identifier: 07630030825804
• UDI-Public: 07630030825804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/14/2020

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: 02/17/2025
• Device Model Number: 02.12.0002R
• Device Catalogue Number: 02.12.0002R
• Device Lot Number: 1909465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2020
• Initial Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR