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

Model Number	02.12.0002R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: 2 years after primary cemented tka, a revision is required mainly because of a cyst developed at the lateral femoral condyle and an opportunity to improve femoral rotation.No relation to a faulty device.Batch review performed on 007.02.2020: lot 146565: (b)(4) items manufactured and released on 24-oct-2014.Expiration date: 2019-09-30.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 since 2016.
Event or Problem Description
Revision surgery performed after 2 years and 2 months after the primary due to patella pain and femoral component rotation and posterior-lateral condyle defect due to a cyst (the cyst didn't cause the rotation).All implants were revised.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9757034
• Report Number: 3005180920-2020-00092
• Device Sequence Number: 2456858
• Product Code: JWH
• UDI-Device Identifier: 07630030825804
• UDI-Public: 07630030825804
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: 09/30/2019
• Device Model Number: 02.12.0002R
• Device Catalogue Number: 02.12.0002R
• Device Lot Number: 146565
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/26/2020
• 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: 72 YR
• Patient Weight: 72