MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R

Model Number	02.07.2206R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-mar-2020: lot 134200: (b)(4) items manufactured and released on 18-oct-2013.Expiration date: 30.09.2018.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: total knee revision surgery performed 4 years and 4 months after cemented tka in a 62 year old active man.Bone alterations involving femur, tibia and patella are visible in the radiographic images provided, but we have no clues as to their possible origin.Aseptic loosening is a possible literature described adverse event after tka and causes are often unknown.High level of activity may be a risk factor for aseptic loosening but also other unknown conditions may have contributed to this failure.The metaphyseal bone alterations are unusually significant and must have contributed in a determinant measure to the loosening.The reason of this event cannot be determined.Other device involved in the event: gmk-primary 02.07.1205r tibial tray fixed cemented size 5 r lot.153498 (k090988).Batch review performed on 22-mar-2020: lot 153498: (b)(4) items manufactured and released on 24-aug-2015.Expiration date: 30.06.2020.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to loosening of the entire prosthesis, patella as well, after about 5 years from the primary surgery.All components have been removed.

• Brand Name: GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R
• Common Device Name: FEMUR PS CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9961874
• Report Number: 3005180920-2020-00241
• Device Sequence Number: 480804
• Product Code: JWH
• UDI-Device Identifier: 07630030820892
• UDI-Public: 07630030820892
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: No Information
• Device Expiration Date: 09/30/2018
• Device Model Number: 02.07.2206R
• Device Catalogue Number: 02.07.2206R
• Device Lot Number: 134200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/15/2020
• 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: 62 YR
• Patient Weight: 80